Identity
- Trade Name
- Avenir Complete® FDA UDI
- Generic Name
- Orthopaedic osteotome blade, reusable FDA UDI
- Model / Reference
- 574777444 FDA UDI
Identifiers
- Catalog Number
- 574777444 FDA UDI
- Primary DI / UDI-DI
- 00889024509894 FDA UDI
- 510(k) Number
- K182048 FDA UDI
- FDA Product Code
- MEH FDA UDILWJ FDA UDILZO FDA UDIKWY FDA UDIKWZ FDA UDI
- GMDN Term
- Orthopaedic osteotome blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3390 FDA UDI888.3310 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
Dimensions & Sizes
- Size
- Length — 46.00 Millimeter FDA UDI
Category: Orthopaedic osteotome blade, reusable
Avenir Complete® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome blade, reusable.
- SHORT ACETABULAR BLADE D44 mm LONG — HPF SRL · Class I
- Shukla Knee S9KNEE — Shukla Medical · Class I
- Discovery™ — Biomet Orthopedics, Inc. · Class I
- RP Medical — Rp Medical, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- TC-100 — Smith & Nephew, Inc. · Class II
- DISCOVERY 2.4MM X-LOCK — Biomet Orthopedics, Inc. · Class I
- ARTHROSCOPIC SCALPEL KNIFE — SONTEC INSTRUMENTS, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 71c53880-0663-4d32-9055-8eded1eb731c 36 fields · synced May 30, 2026