Exactech, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 63 건

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
  • 제품 설명
    Equinoxe 44mm Short Humeral Head || Catalog Number 310-01-44. || Orthopedic shoulder implant component.
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 05-100-03-0042, Lot # 68122001.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to Florida only.
  • 제품 설명
    Exactech Ambassador Cervical Plate System || The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 05-109-14-0000, Lot # 68266001.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to Florida only.
  • 제품 설명
    Exactech Single Barrel Drill Guides || The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 28202, Lot Number AS05107
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of FL, GA, IL, NY, TX, and WA.
  • 제품 설명
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. || Intended to provide immobilization and stabilization of spinal segments.
  • 모델명 / 제조번호(시리얼번호)
    Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribuiton to OK, ME, NY, & Hawaii.
  • 제품 설명
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. || Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
하나 더 58 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Exactech, Inc., 2320 N.W. 66th Court, Gainesville FL 32653
  • Source
    USFDA