510(k) K232652 ยท HRS Plate, Fixation, Bone
Anatomical Plating System (various)
| Applicant | Tyber Medical, LLC, Bethlehem PA, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Aug 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232652
| 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/10Shaft/Left/Std/139mm
Model/Catalog Number: 02.426.681S
Product Description: 2 Column Distal Radius Plate Open, Classified |
HRS | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.