Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- Humeral Resurfacing Arthroplasty FDA UDI
- Model / Reference
- SHP9004418 FDA UDI
- Description
- Humeral Resurfacing Arthroplasty FDA UDI
Identifiers
- Catalog Number
- SHP-900-44/18 FDA UDI
- Primary DI / UDI-DI
- 10381780237211 FDA UDI
- 510(k) Number
- K062861 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Bone cutter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI
- Commercial Distribution
- 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutter
Integra® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062861 also covers:
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — 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 f57cfe10-84cc-49d4-b3c0-08956340094d 38 fields · synced May 30, 2026