510(k) K110445 ยท HWC Screw, Fixation, Bone
FLEXFUSION (TM) FIXATION IMPLANT
| Applicant | Nextremity Solutions, LLC, Colts Neck NJ, US |
| Decision | Substantially Equivalent, Mar 17, 2011 |
| Received | Feb 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit
SKU: NX-4532K
Orthopedic surgical instrument Terminated |
HWC | None listed |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-4532K-SC
Orthopedic surgical instrument Terminated |
HWC | None listed |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit
SKU: NX-3532K
Orthopedic surgical instrument Terminated |
HWC | None listed |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-3532K-SC
Orthopedic surgical instrument Terminated |
HWC | None listed |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System Driver
SKU: NX-DR
Orthopedic surgical instrument Terminated |
HWC | None listed |
| Feb 24, 2020 | Nextremity Solutions Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.
REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments w Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.