RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678

Orthopedic Devices

2

Yes

US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.

RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) || Product Usage: || When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK

Orthopedic Devices

2

Yes

US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019

Orthopedic Devices

2

Yes

Distributed in MA.

Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. || The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

Part Number: 32-13-32 Lot: 200827 Expiration Date: 2019-12-18 Part Number: 30-T-13-6 Lot: 202726 Expiration Date: 2020-01-16  Part Number: 30-T-1036-13-6 Lot: 202582 Expiration Date: 2020-01-15

Orthopedic Devices

2

Yes

US Distribution to the states of : FL and NY

Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral || Body Replacement System to ensure stability of the spine and adequate compression of the implant.