Identity
- Trade Name
- Stablyx FDA UDI
- Generic Name
- Metacarpal prosthesis FDA UDI
- Model / Reference
- STABLYX, CMC Trial, Sz. 5 FDA UDI
Identifiers
- Catalog Number
- STX-CMA-TS5 FDA UDI
- Primary DI / UDI-DI
- 00841506103280 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Metacarpal prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Metacarpal prosthesis
Stablyx by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metacarpal prosthesis.
- Ascension® NuGrip® — Ascension Orthopedics, Inc. · Class II
- ATLAS — PARCUS MEDICAL LLC · Class II
- TOUCH® CMC 1 — Keri Medical SA · Class III
- Ensemble CMC — Ensemble Orthopedics, LLC · Class II
- PyroSphere CMC — Smith & Nephew, Inc. · Class II
- Ensemble CMC — Ensemble Orthopedics, LLC · Class II
- TOUCH® CMC 1 — Keri Medical SA · Class III
- SWANSON — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 0c296af5-ff64-4ac3-bd4f-00bfe2937c6a 34 fields · synced May 31, 2026