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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Tyber Medical with 31 510(k) clearances and 20 device recalls. The most recent is a 510(k) clearance dated Jun 12, 2026: Exalta Proximal Tibia Plating 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.
| Jun 12, 2026 | Exalta Proximal Tibia Plating SystemK261207 · HRS | 510(k) clearances |
| Jun 10, 2026 | Anteralign LS coverplateK260810 · OVD | 510(k) clearances |
| May 29, 2026 | Navigated LLIF Impactable TrackerK261060 · OLO | 510(k) clearances |
| Apr 3, 2026 | Tyber Medical Trauma ScrewK253042 · HWC | 510(k) clearances |
| Dec 31, 2025 | Tyber Medical Trauma ScrewK252901 · HWC | 510(k) clearances |
| Dec 19, 2025 | Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: Class II · The supplier manufactured anatomical left plates with an incorrect thread orientation. | Device recalls |
| Dec 19, 2025 | Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: Class II · The supplier manufactured anatomical left plates with an incorrect thread orientation. | Device recalls |
| Oct 28, 2025 | Navigated InstrumentsK252742 · OLO | 510(k) clearances |
| Jul 30, 2025 | Tyber Medical Distal Radius Plating SystemK251361 · HRS | 510(k) clearances |
| Mar 19, 2025 | Tyber Medical Anatomical Plating SystemK242486 · HRS | 510(k) clearances |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/CatalClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | Device recalls |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/CataloClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | Device recalls |
| Jan 21, 2025 | A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/CaClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | Device recalls |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/CataloClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | Device recalls |
| Jan 21, 2025 | A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of tClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | Device recalls |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/CatalClass II · Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial | 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
