Identity
- Trade Name
- NuGrip CMC FDA UDI
- Generic Name
- Metacarpal prosthesis FDA UDI
- Device Name
- NUGRIP SZ. 30S FDA UDI
- Model / Reference
- NUG-443-30S FDA UDI
- Description
- NUGRIP SZ. 30S FDA UDI
Identifiers
- Catalog Number
- NUG-443-30S FDA UDI
- Primary DI / UDI-DI
- 00885556857809 FDA UDI
- 510(k) Number
- K112278 FDA UDI
- FDA Product Code
- KYI FDA UDI
- GMDN Term
- Metacarpal prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3770 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
NuGrip CMC by Smith & Nephew, Inc. — 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
- ATLAS — PARCUS MEDICAL LLC · 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
- Stablyx — SKELETAL DYNAMICS L.L.C. · Class II
Cleared under the same submission
K112278 also covers:
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Ascension® NuGrip® — Ascension Orthopedics, Inc.
- Integra® NuGrip® — Ascension Orthopedics, Inc.
- Integra® NuGrip® — Ascension Orthopedics, Inc.
- Integra® NuGrip® — Ascension Orthopedics, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 98dc9f8d-1ad8-4a76-a6d7-62a62b3919e6 36 fields · synced Jun 8, 2026