Identity
- Trade Name
- ATLAS FDA UDI
- Generic Name
- Metacarpal prosthesis FDA UDI
- Device Name
- ATLAS FDA UDI
- Model / Reference
- 11200 FDA UDI
- Description
- ATLAS FDA UDI
Identifiers
- Catalog Number
- 11200 FDA UDI
- Primary DI / UDI-DI
- M685112000 FDA UDI
- 510(k) Number
- K190375 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Metacarpal prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metacarpal prosthesis
Atlas by Parcus Medical Llc — 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
- Stablyx — SKELETAL DYNAMICS L.L.C. · Class II
- TOUCH® CMC 1 — Keri Medical SA · Class III
- Stablyx — SKELETAL DYNAMICS L.L.C. · Class II
- Stablyx — SKELETAL DYNAMICS L.L.C. · Class II
- Ensemble CMC — Ensemble Orthopedics, LLC · Class II
- PyroSphere CMC — Smith & Nephew, Inc. · Class II
- Stablyx — SKELETAL DYNAMICS L.L.C. · 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 |
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Manufacturer
- Manufacturer
- Parcus Medical Llc
Sources (1)
- FDA UDI a06e990c-8895-4374-88df-f9ccf5693414 36 fields · synced May 30, 2026