데이터베이스 소개
국제 의료기기 데이터베이스 사용법
데이터 다운받기
FAQ
출처표기
Manufacturers
Allez Spine, LLC
제조사 주소
Allez Spine, LLC, 2301 Dupont Dr Ste 510, Irvine CA 92612-7518
제조사 모회사 (2017)
Allez Spine Llc
Source
USFDA
22 Events
Device Recall Allez Spine Cross Connectors 의 리콜
Device Recall Allez Spine Del Mar Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
Device Recall Allez Spine Laguna Pedicle Screw System 의 리콜
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 22 건
Device Recall Allez Spine Cross Connectors
모델명 / 제조번호(시리얼번호)
All Serial Numbers
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
제품 설명
Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 || Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm
Device Recall Allez Spine Del Mar Pedicle Screw System
모델명 / 제조번호(시리얼번호)
All Serial Numbers
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
제품 설명
Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 || Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); || IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher; || lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001 || Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl Bearing); IT-CT1002 Counter Torque (Short No Windows); || IT-SD1006 Multiaxial Screwdriver (w/Windows); || IT-TP1005 Tap, 4mm (Silver Tn-Fluted); || IT-TP1006 Tap, 5mm (Silver Tn-Fluted); || IT-TP1007 Tap, 6mm (Silver Tn-Fluted); || IT-TP1008 Tap, 7mm (Silver Tn-Fluted); || lT-HP1002 Head Positioner (All Metal Handle); || IT-RK1002 Rocker (Horse Shoe Style Tip); || IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing); || IT-CT1003 Counter Torque (Short w/Windows); || IT-TP1014 Tap, 4mm (Silver Circumferential); || IT-TP1015 Tap, 5mm (Silver Circumferential); || IT-TP1016 Tap, 6mm (Silver Circumferential); || IT-TP1017 Tap, 7mm (Silver Circumferential); || IT-SD1007 Screwdriver Shaft 8.5 (No Ball Bearing); || IT-XR1001 Extension Remover; || IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing); || IT-FB1001 French Rod Bender; || IT-SP1001 Ball Tip Probe; || IT-TR1001 Trial Rod; || IT-RG 1002 Rod Gripper, Ratcheting (Short Nose); || IT-BP1003 Lumbar Probe, Straight (Long); || IT-BP1004 Lumbar Probe, Curved (Long); || IT-SP1002 Sounder (Ball Tip) Probe, Heavy Duty; || RD-ST5540 Rod 5,5 x 400mm, Straight; || IT-BA1001 Newport Awl; || IT-PU 1001 Persuader; || IT-RR1001 Retaining Ring; || lT-NS1001 In-Situ Left; || IT-N51002 In-Situ Right; || IT-BP100S Lumbar Probe, Straight (Short); || IT-BP1006 Lumbar Probe, Curved (Short); || IT-CP1001 Compressor; || IT-DT1001 Distractor; || IT-BP1001 Thoracic Ball Handle Probe, Curved; || IT-BP1002 Thoracic Ball Handle Probe, Straight; || IT-RH1002 Ratcheting T-Handle; || IT-NC1001 Locking Nut Caddy; || IT-SG1001 Screw Gauge Block; || IT-RH1002 Ratcheting Handle, Straight; || IT-T01002 Preset Torque Wrench (With Connector); || LG-LN1002 Locking Nut, Single Piece; || LG-PR0530C Polyaxial Screw, Non-Winged, 5 X 30; || LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35; || LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40; || LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45; || LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50; || LG-PR0630C Polyaxial Screw, Non-Winged, 6 X 30; || LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; || LG-PR0640C Polyaxial Screw, Non-Winged, 6 X 40; || LG-PR0645C Polyaxial Screw, Non-Winged, 6 X 45; || LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; || LG-PR0730C Polyaxial Screw, Non-Winged, 7 X 30; || LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35; || LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40; || LG-PR074SC Polyaxial Screw, Non-Winged, 7 X 45; || LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50; || LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55; || LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35; || LG-PR0840C Polyaxial Screw, Non-Winged, 8 X 40; || LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45; || LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50; || LG-PR0855C Polyaxial Screw, Non-Winged, 8)( 55; || LG-PW0535C Polyaxial Screw, Winged, S X 35; || LG-PW0540C Polyaxial Screw, Winged, 5 X 40; || LG-PW0545C Polyaxial Screw, Winged, 5 X 45; || LG-PW0635C Polyaxial Screw, Winged, 6 X 35; || LG-PW0640C Polyaxial Screw, Winged, 6 X 40; || LG-PW0645C Polyaxial Screw, Winged, 6 X 45; || LG-PW0735C Polyaxial Screw, Winged, 7 X 35; || LG-PW0740C Polyaxial Screw, Winged, 7 X 40; || LG-PW0745C Polyaxial Screw, Winged, 7 X 45; || RD-PB5504 ROD 5.5 X 40, PRE-BENT; || RD-PB5505 ROD 5.5 X 50, PRE-BENT; || RD-PB5506 ROD 5.5 X 60, PRE-BENT; || RD-PB5507 ROD 5.5 X 70, PRE-BENT; || RD-PB5508 ROD 5.5 X 80, PRE-BENT; || RD-PB5509 ROD 5.5 X 90, PRE-BENT; || RD-PB5510 ROD 5.5 X 100, PRE-BENT; || RD-PB5511 ROD 5.5 X 110, PRE-BENT; || RD-PB5
Device Recall Allez Spine Laguna Pedicle Screw System
모델명 / 제조번호(시리얼번호)
All Serial Numbers
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
제품 설명
Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 || Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; || IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 || Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; || DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 || Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; || DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; || DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 || Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 || DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex || Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
Device Recall Allez Spine Laguna Pedicle Screw System
모델명 / 제조번호(시리얼번호)
LG-PW0745
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide to AZ, CA, CO & UT
제품 설명
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745
Device Recall Allez Spine Laguna Pedicle Screw System
모델명 / 제조번호(시리얼번호)
LG-PW0740
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide to AZ, CA, CO & UT
제품 설명
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740
하나 더 17 건 더
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건
데이터에 대해 더 자세히 알아보기
여기
Allez Spine, LLC
제조사 주소
Allez Spine, LLC, 2301 Dupont Drive, Suite 510, Irvine CA 92612
제조사 모회사 (2017)
Allez Spine Llc
Source
USFDA
Language
English
Français
Español
한국어