Identity
- Trade Name
- Alliance® FDA UDI
- Generic Name
- Orthopaedic osteotome blade, reusable FDA UDI
- Model / Reference
- SBGL1007 FDA UDI
Identifiers
- Catalog Number
- SBGL1007 FDA UDI
- Primary DI / UDI-DI
- 00889024574625 FDA UDI
- 510(k) Number
- K191814 FDA UDI
- FDA Product Code
- KWT FDA UDIKWS FDA UDI
- GMDN Term
- Orthopaedic osteotome blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 FDA UDI888.3660 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: Orthopaedic osteotome blade, reusable
Alliance® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome blade, reusable.
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- 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
K191814 also covers:
- 3 Peg Mod Drill Guide Sz 1 — Zimmer, Inc.
- 3 Peg Mod Drill Guide Sz 2-5 — Zimmer, Inc.
- Alliance Non-Cann Ctr Post Dr — Zimmer, Inc.
- Alliance Non-Cann Rmr Sz 2 — Zimmer, Inc.
- Alliance Non-Cann Rmr Sz 3 — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — Zimmer, Inc.
- Alliance® — 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 98a9ceb5-d159-4b7a-8a52-d9b4edf15bc1 35 fields · synced Jun 8, 2026