A.L.P.S. mvX™ 770200030
Ref 770200030
A.L.P.S. mvX™ 770200030 is a device classified as Class IIb in the EU and Class II in the US made by Tyber Medical, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 019644902256) and listed in FDA GUDID since 15 Dec 2023 (UDI-DI 00196449012985), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number019644902256 00196449012985 | Date7 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00196449012985 | Date15 Dec 2023 | StatusListed |
Official records
- EUDAMED public site 019644902256
- AccessGUDID record 00196449012985
Across registries
- EUDAMED Basic UDI-DI 019644902256 registered 7 May 2026 Active
- FDA GUDID UDI-DI 00196449012985 listed 15 Dec 2023 Listed
Timeline
- Listed FDA GUDID 00196449012985
- Registered EUDAMED 019644902256
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- A.L.P.S. mvX™
- Generic name
- Orthopaedic bone screw (non-sliding)
- Device name
- Titanium Alloy Non-Locking Screws
- Model / Ref / Catalog
- 770200030
- Primary DI / UDI-DI
- 00196449012985
- Basic UDI-DI
- 019644902256
- FDA product code
- HWC
- EMDN code
- P09120503 Osteosynthesis screw-plate systems
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 888.3040
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 00196449012985: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
Similar devices in this category
Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.
- Arthrex® AR-8970TTC-05S by Arthrex, Inc.
- A.L.P.S.® 8162-07-008 816207008 by Biomet Orthopedics, Inc.
- Orthomed E® Bone Fixation Plates 6222049655797 by Orthomed E
- MC MC.MLP.301-03 by Medical Consept Sağlık Turz. San. Tic. Ltd. Şti.
- TraumaOne SYSTEM SP-2618 by BIOMET MICROFIXATION, INC
- DVR® CROSSLOCKVOLAR RIM PLATE 131825050 by Biomet Orthopedics, Inc.
- Arthrex® AR-2651CRS by Arthrex, Inc.
- Omni Stable AF 155-25700 by Extremity Medical, LLC
- TraumaOne SYSTEM 01-7039 by BIOMET MICROFIXATION, INC
- 00-2358-107-05 by Zimmer, Inc.