Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nextremity Solutions with 20 510(k) clearances and 15 device recalls. The most recent is a 510(k) clearance dated Nov 4, 2022: Nextra CH Cannulated Hammertoe System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 4, 2022 | Nextra CH Cannulated Hammertoe SystemK221610 · HWC | 510(k) clearances |
| May 20, 2022 | CalcShift™ Displacement Calcaneal Osteotomy SystemK212979 · HRS | 510(k) clearances |
| Mar 22, 2022 | StealthFix Intraosseous Fixation SystemK220181 · JDR | 510(k) clearances |
| Feb 10, 2022 | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrumentClass II · Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from th | Device recalls |
| Feb 10, 2022 | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrumentClass II · Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from th | Device recalls |
| Feb 10, 2022 | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrumentClass II · Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from th | Device recalls |
| Feb 10, 2022 | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrumentClass II · Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from th | Device recalls |
| Feb 10, 2022 | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrumentClass II · Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from th | Device recalls |
| Jan 13, 2022 | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of theClass II · During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result | Device recalls |
| Jan 13, 2022 | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of thClass II · During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result | Device recalls |
| Dec 21, 2021 | InCore Subtalar SystemK213301 · HWC | 510(k) clearances |
| Dec 9, 2021 | Nextra CH Cannulated Hammertoe SystemK213530 · HWC | 510(k) clearances |
| Nov 18, 2021 | Stratum® Ankle Fusion Plating SystemK212640 · HRS | 510(k) clearances |
| Sep 23, 2021 | Nexta PEEK Hammertoe Correction SystemK211996 · HWC | 510(k) clearances |
| Mar 26, 2021 | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fClass II · Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing th | Device recalls |
| Jul 27, 2020 | Stratum™ Reduced Size Foot Plating SystemK200785 · HRS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
