SpineFrontier, Inc.

Lot/Serial Numbers: 357305-000

Orthopedic Devices

2

Yes

US Distribution to VA and TX.

PedFuse Reset Screw; Model: 01-80115-55 || The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Lot: 012212-001

Orthopedic Devices

1

No

US Distribution: including states of: TX and VA.

PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

31176, 018652, 018645R, 42011

General and Plastic Surgery Devices

1

No

US distribution in states of: CO, DC, MA and TX.

Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B || The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

VM13222- 34489

Orthopedic Devices

2

Yes

US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 || The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

VM 13194-34457

Orthopedic Devices

2

Yes

US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 || The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.