510(k) K123164 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
| Applicant | Spinefrontier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Feb 15, 2013 |
| Received | Oct 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2015 | SpineFrontier, Inc. SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Terminated |
FTY | None listed |
| Jan 3, 2014 | SpineFrontier, Inc. PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Terminated |
HXB | None listed |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw c Terminated |
MNI | None listed |
| Dec 20, 2013 | SpineFrontier, Inc. 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 Terminated |
MNI | None listed |
| Dec 20, 2013 | SpineFrontier, Inc. 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 c Terminated |
MNI | None listed |
| Dec 19, 2013 | SpineFrontier, Inc. 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 Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.