Tyber Medical

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
27
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1132-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14ShafDecember 19, 2025
Z-1131-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10ShafDecember 19, 2025
Z-1211-2025Class IIA.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended foJanuary 21, 2025
Z-1216-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. IntendeJanuary 21, 2025
Z-1212-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/CataJanuary 21, 2025
Z-1213-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended toJanuary 21, 2025
Z-1217-2025Class IIA.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. InendeJanuary 21, 2025
Z-1224-2025Class IIA.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation ofJanuary 21, 2025
Z-1209-2025Class IIA.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended fJanuary 21, 2025
Z-1222-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fracJanuary 21, 2025
Z-1218-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. IntendeJanuary 21, 2025
Z-1219-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fraJanuary 21, 2025
Z-1215-2025Class IIA.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, LeJanuary 21, 2025
Z-1223-2025Class IIA.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of frJanuary 21, 2025
Z-1221-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of frJanuary 21, 2025
Z-1210-2025Class IIA.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/CataJanuary 21, 2025
Z-1214-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated January 21, 2025
Z-1226-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of frJanuary 21, 2025
Z-1225-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of January 21, 2025
Z-1220-2025Class IIA.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 7707January 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K252901Tyber Medical Trauma ScrewDecember 31, 2025
K252742Navigated InstrumentsOctober 28, 2025
K251361Tyber Medical Distal Radius Plating SystemJuly 30, 2025
K242486Tyber Medical Anatomical Plating SystemMarch 19, 2025
K241218Tyber Medical Anatomical Plating SystemMay 31, 2024
K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemDecember 21, 2023
K233017TM Plating SystemDecember 20, 2023
K232652Anatomical Plating System (various)December 13, 2023
K232693Tyber Medical Distal Radius Plating SystemDecember 4, 2023
K231339Tyber Medical Pin and Wire System (various)July 6, 2023
K222465Tyber Medical Anatomical Plating SystemMarch 7, 2023
K221947Tyber Medical Staple Fixation System (various)October 20, 2022
K203817Tyber Medical Anatomical Plating SystemAugust 13, 2021
K193222Tyber Medical Anatomical Plating SystemJanuary 20, 2020
K192975Tyber Medical Trauma ScrewsJanuary 9, 2020
K192974Tyber Medical Trauma ScrewJanuary 8, 2020
K182284Tyber Medical PT Interbody SpacerJanuary 18, 2019
K180590Tyber Medical PT Interbody Spacer SystemJuly 6, 2018
K172185Tyber Medical PT Interbody Spacer SystemDecember 21, 2017
K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix ScrewJune 20, 2017