Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 8 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Enovis and its 8 subsidiaries with 259 510(k) clearances, 50 device recalls and 1 drug application. The most recent is a 510(k) clearance dated Sep 29, 2026: Spinalogic Bone Growth Stimulator.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Enovis and its 8 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 29, 2026 | Spinalogic Bone Growth StimulatorK262721 · LOF | 510(k) clearances |
| Jan 22, 2026 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemK252352 · PHX | 510(k) clearances |
| Aug 29, 2025 | ArTT Augments and Buttresses and Bone ScrewsK251718 · LPH | 510(k) clearances |
| Jul 3, 2025 | SMR Reverse HP Shoulder SystemK243826 · PHX | 510(k) clearances |
| May 22, 2025 | Physica System (Physica CR Porous Femoral components)K250980 · MBH | 510(k) clearances |
| Mar 4, 2025 | Biolox® Delta Revision headsK243809 · LZO | 510(k) clearances |
| Dec 18, 2024 | Physica Porous Femoral ComponentsK243615 · MBH | 510(k) clearances |
| Jan 18, 2024 | AMF TT ConesK234011 · JWH | 510(k) clearances |
| Mar 27, 2018 | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non SterileClass II · Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation o | Device recalls |
| Mar 27, 2018 | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non SterileClass II · Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation o | Device recalls |
| Dec 8, 2016 | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixatiClass II · Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wir | Device recalls |
| Sep 2, 2016 | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOTClass II · Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly | Device recalls |
| Aug 6, 2015 | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERIClass II · The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw | Device recalls |
| Jul 31, 2015 | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock PlatiClass II · Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the poten | Device recalls |
| Jul 20, 2015 | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; CoClass II · The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. | Device recalls |
| Jul 20, 2015 | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are componentsClass II · Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be diffi | Device recalls |
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
