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Sign in to claim this brandTyber Medical
United States·US-MF-000011350
Last updated September 17, 2026
What Tyber Medical makes
Tyber Medical manufactures orthopaedic fixation devices, including non-sliding titanium alloy and stainless steel wrist plates, cannulated compression headless screws, and reusable surgical drill guides. Their portfolio also includes spinal interbody fusion cages—both metal-polymer composites and non-customized metallic/polymeric types—along with phalangeal joint arthrodesis implants and reusable instrumentation trays. Navigation-assisted spinal tools, such as the Navigated LLIF Impactable Tracker, and modular fixation systems like the Snap-Off Screw System are also part of their offerings.
The company’s devices are regulated under FDA 510(k) and UDI listings in the US, with Class I, Class II, and Class IIb classifications. Their products are also recorded in the EU’s eudamed registry, reflecting compliance with relevant medical device directives. Tyber Medical operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 83, South Commerce Way, Bethlehem, United States
- Website
- tybermedical.com/
- —
- —
- [email protected]
- Phone
- +1 866-761-0933
- PRRC Contact
- Lisa Boyle
- EUDAMED SRN
- US-MF-000011350
- FDA FEI Number
- 3017980495
- DUNS Number
- —
Catalogue (10381)
Page 14 of 208| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tyber Medical | Headless Ø6.5 x 75mm Long Thread Ti (Torx) | FDA UDI | Class II | Active |
| Tyber Medical | 302-P2412812-S | FDA UDI | Class II | Active |
| Tyber Medical | 502-P281548-S | FDA UDI | Class II | Active |
| Tyber Medical | Headed Cannulated Screw Long Ø3.0mm x 28mm | FDA UDI | Class II | Active |
| A.L.P.S. mvX™ | 770271100 | FDA UDI | Class II | Active |
| LEOS Cannulated Screw System | 76335552FT | FDA UDI | Class II | Active |
| Orion Headed Screw | HTR-04-454555 | FDA UDI | Class II | Active |
| Orion Headed Screw System Instruments | HTR-04-009735 | FDA UDI | Class I | Active |
| A.L.P.S. mvX™ | 770706060 | EUDAMEDFDA UDI | Class II | Active |
| A.L.P.S. mvX™ | 770270008 | EUDAMEDFDA UDI | Class II | Active |
| A.L.P.S. mvX™ | 770718442 | EUDAMEDFDA UDI | Class II | Active |
| Tyber Medical | Headed Cannulated Screw Long Ø3.0mm x 14mm | FDA UDI | Class II | Unknown |
| P-tanium Wedge | TOCOTW154P-S | FDA UDI | Class II | Active |
| Tyber Medical | 302-P301008-S | FDA UDI | Class II | Active |
| Headless Screw System | 401-20211 | FDA UDI | Class II | Active |
| Headed Screw System Instruments | 009-000045 | FDA UDI | Class I | Active |
| Leos | 7624-5201 | FDA UDI | Class I | Active |
| LEOS Cannulated Screw System | 76347095SH | FDA UDI | Class II | Active |
| Orion Headed Screw | HTR-04-404550 | FDA UDI | Class II | Active |
| Cannulated Compression Headless Screw | 1ZB50336 | FDA UDI | Class II | Active |
| Tyber Medical | 302-P289010-S | FDA UDI | Class II | Active |
| Tyber Medical | 302-P30728-S | FDA UDI | Class II | Active |
| Fps | M25-401038 | FDA UDI | Class II | Active |
| LEOS Cannulated Screw System | 76308823 | FDA UDI | Class I | Active |
| Tyber Medical | 502-T2811501-S | FDA UDI | Class II | Active |
| Tyber Medical | Headless Ø4.5 x 26mm Long Thread Ti (Torx) | FDA UDI | Class II | Unknown |
| Tyber Medical | 302-P2416810-S | FDA UDI | Class II | Active |
| Headless Screw System Instruments | 001-000002 | FDA UDI | Class I | Active |
| ACIS® ProTi 360™ HL | 208843019 | FDA UDI | Class II | Active |
| LEOS Cannulated Screw System | 76312518 | FDA UDI | Class II | Active |
| TPLIF Interbody System | M2-T3013524-S | FDA UDI | Class II | Active |
| Tyber Medical | 502-P269012-S | FDA UDI | Class II | Active |
| Cannulated Compression Headless Screw | 1ZB802115 | FDA UDI | Class II | Active |
| Cannulated Compression Headless Screw | 1ZB654110 | FDA UDI | Class II | Active |
| Orion Ti PEEK Wedge System Instruments | HTR-04-004965 | FDA UDI | Class I | Active |
| Snap-Off Screw System | 410-20313 | FDA UDI | Class II | Active |
| Headless Screw System | 401-20322 | FDA UDI | Class II | Active |
| SteriToe HT | MMHT-2X13C | FDA UDI | Class II | Active |
| Fps | F25-007120 | FDA UDI | Class I | Active |
| Foot Osteotomy Wedge System | 03.844.105 | FDA UDI | Class I | Active |
| Tyber Medical | 302-P3014012-S | FDA UDI | Class II | Active |
| Tyber Medical | 502-P2215412-S | FDA UDI | Class II | Active |
| CONCORDE® ProTi 360°™ | 188827107 | FDA UDI | Class II | Active |
| Tyber Medical | 502-P269412-S | FDA UDI | Class II | Active |
| Tyber Medical | Headed Cannulated Screw Long Ø3.0mm x 32mm | FDA UDI | Class II | Active |
| Fps | M25-352010 | FDA UDI | Class II | Active |
| Cannulated Compression Headless Screw | 1ZB40326 | FDA UDI | Class II | Active |
| Cannulated Compression Headless Screw | 1ZB803130 | FDA UDI | Class II | Active |
| Leos | 7621-4030 | FDA UDI | Class II | Active |
| LEOS Cannulated Screw System | 76325590LG | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (20)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Tyber Medical has initiated 20 recall records between January 21, 2025, and December 19, 2025, with some classified and others remaining open. The reasons cited include manufacturing defects in anatomical left plates, specifically incorrect thread orientation, and complaints of locking screws failing to secure properly during surgery, leading to reported surgical delays.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Z-1131-2026 | — | open, classified | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Dec 19, 2025 | Z-1132-2026 | — | open, classified | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Jan 21, 2025 | Z-1214-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1209-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1223-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1226-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1211-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1225-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1216-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1213-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1224-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1210-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1219-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1217-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1218-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1222-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1220-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1212-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1215-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Z-1221-2025 | — | open, classified | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |