Identity
- Trade Name
- Avenir Complete® FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Model / Reference
- 574888085 FDA UDI
Identifiers
- Catalog Number
- 574888085 FDA UDI
- Primary DI / UDI-DI
- 00889024510081 FDA UDI
- 510(k) Number
- K182048 FDA UDI
- FDA Product Code
- LZO FDA UDIKWZ FDA UDILWJ FDA UDIKWY FDA UDIMEH FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3310 FDA UDI888.3360 FDA UDI888.3390 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 file/rasp, manual, reusable
Avenir Complete® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182048 also covers:
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, Inc.
- Avenir Complete® — Zimmer, 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
- Zimmer, Inc.
Sources (1)
- FDA UDI 2769c0b9-18b5-4c30-ac9d-d352b823d815 36 fields · synced Jun 8, 2026