Identity
- Trade Name
- A.L.P.S. mvX™ FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Titanium Alloy Screw Washers EUDAMED4.0MM SCREW WASHER FDA UDI
- Model / Reference
- 770800040 EUDAMEDFDA UDI
- Description
- 4.0MM SCREW WASHER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00196449016396 EUDAMEDFDA UDI
- Basic UDI-DI
- 019644902052 EUDAMED
- FDA Product Code
- HTN FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Implantable bone washer
A.L.P.S. mvX™ by Tyber Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
- Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- FacetLink System — WALDEMAR LINK GmbH & Co. KG · U
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tyber Medical
Sources (2)
- FDA UDI 8af16c65-ddf8-49b2-8e2d-7ac5a5622771 34 fields · synced Jun 19, 2026
- EUDAMED aed58d58-c7aa-4b2b-8eb1-67e0d638ea6c 61 fields · synced Jun 14, 2026