Company · US
Tyber Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (5 in 12 months)
20recalls (2 in 12 months)
20recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K261207 | Exalta Proximal Tibia Plating System Tyber Medical, LLC | HRS |
| Jun 10, 2026 | K260810 | Anteralign LS coverplate Tyber Medical, LLC | OVD |
| May 29, 2026 | K261060 | Navigated LLIF Impactable Tracker Tyber Medical, LLC | OLO |
| Apr 3, 2026 | K253042 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Dec 31, 2025 | K252901 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Oct 28, 2025 | K252742 | Navigated Instruments Tyber Medical, LLC | OLO |
| Jul 30, 2025 | K251361 | Tyber Medical Distal Radius Plating System Tyber Medical, LLC | HRS |
| Mar 19, 2025 | K242486 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| May 31, 2024 | K241218 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| Dec 21, 2023 | K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System Tyber Medical, LLC | HRS |
| Dec 20, 2023 | K233017 | TM Plating System Tyber Medical, LLC | HRS |
| Dec 13, 2023 | K232652 | Anatomical Plating System (various) Tyber Medical, LLC | HRS |
| Dec 4, 2023 | K232693 | Tyber Medical Distal Radius Plating System Tyber Medical, LLC | HRS |
| Jul 6, 2023 | K231339 | Tyber Medical Pin and Wire System (various) Tyber Medical, LLC | HTY |
| Mar 7, 2023 | K222465 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| Oct 20, 2022 | K221947 | Tyber Medical Staple Fixation System (various) Tyber Medical, LLC | JDR |
| Aug 13, 2021 | K203817 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| Jan 20, 2020 | K193222 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| Jan 9, 2020 | K192975 | Tyber Medical Trauma Screws Tyber Medical, LLC | HWC |
| Jan 8, 2020 | K192974 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Jan 18, 2019 | K182284 | Tyber Medical PT Interbody Spacer Tyber Medical, LLC | ODP |
| Jul 6, 2018 | K180590 | Tyber Medical PT Interbody Spacer System Tyber Medical, LLC | ODP |
| Dec 21, 2017 | K172185 | Tyber Medical PT Interbody Spacer System Tyber Medical, LLC | ODP |
| Jun 20, 2017 | K170571 | Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw Tyber Medical, LLC | HWC |
| May 16, 2017 | K171327 | Tyber Medical Wedge System Tyber Medical, LLC | PLF |
| Nov 16, 2016 | K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw Tyber Medical, LLC | HWC |
| Feb 26, 2016 | K153575 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Nov 25, 2015 | K153180 | Tyber Medical MST Trauma Screw Tyber Medical, LLC | HWC |
| Jul 28, 2015 | K150394 | Tyber Medical Wedge System Tyber Medical, LLC | PLF |
| Mar 20, 2014 | K133842 | TYBER MEDICAL TRAUMA SCREW Tyber Medical, LLC | HWC |
| Sep 30, 2013 | K130573 | TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF Tyber Medical, LLC | ODP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2026 | Tyber Medical Brand Name: VOLT" Wrist Treatment System
Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm
Model/Catalog Number: 02.426.691S
Product Description: 2 Column Distal Radius Plate Open, Classified |
HRS | K232652 |
| Jan 20, 2026 | Tyber Medical Brand Name: VOLT" Wrist Treatment System
Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm
Model/Catalog Number: 02.426.681S
Product Description: 2 Column Distal Radius Plate Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right
Intended Fixation of fractures of the distal tibia
Model/Catalog Number: 770715162 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770715161 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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/Catalog Number: 770715122 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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/Catalog Number: 770715121 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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/Catalog Number: 770715102 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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/Catalog Number: 770715101 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right
Model/Catalog Number: 770715062
Intended for Fixation of fractures of the distal tibia Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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/Catalog Number: 770715061 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right.
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708122
Product Description: Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left.
Inended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708121 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right.
Intended forFixation of fractures of the distal tibia
Model/Catalog Number: 770708102
Product Description: Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical 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 the distal tibia
Model/Catalog Number: 770708101 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right
Indicated for use in Fixation of fractures of the distal tibia
Model/Catalog Number: 77070802 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left
Intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Model/Catalog Number: 770708081 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right
Model/Catalog Number: 770708062 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708061 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right
Model/Catalog Number: 770708042 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708041 Open, Classified |
HRS | K232652 |