Identity
- Trade Name
- Integra® NuGrip® FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This set includes trials to evaluate the size and fit of the implant. Instruments are included for assistance. FDA UDI
- Model / Reference
- NUGRIPINSTP FDA UDI
- Description
- The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This set includes trials to evaluate the size and fit of the implant. Instruments are included for assistance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780235019 FDA UDI
- 510(k) Number
- K112278 FDA UDI
- FDA Product Code
- KYI FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3770 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integra® NuGrip® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 36ad367f-6357-44c2-960a-a2983a55765f 37 fields · synced Jun 1, 2026