PIONEER SURGICAL TECHNOLOGY, INC.

Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.

Orthopedic Devices

2

Yes

Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.

STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW || REF 26-SETSCREW || NON-STERILE, SINGLE USE, RX ONLY

Lot number: 148062, 148440

Orthopedic Devices

2

Yes

Nationwide Distribution including TX, CA, IL, and FL.

Streamline MIS Spinal Fixation System Fixed Rod Holder || NON STERILE, Rx only || The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration 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. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018

Orthopedic Devices

2

Yes

US Nationwide Distribution in the states of TX and FL

Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. || The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.