Identity
- Trade Name
- Alliance® FDA UDI
- Generic Name
- Glenoid orthopaedic reamer FDA UDI
- Model / Reference
- SBGL3003 FDA UDI
Identifiers
- Catalog Number
- SBGL3003 FDA UDI
- Primary DI / UDI-DI
- 00889024574724 FDA UDI
- 510(k) Number
- K191814 FDA UDI
- FDA Product Code
- KWT FDA UDIKWS FDA UDI
- GMDN Term
- Glenoid orthopaedic reamer 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: Glenoid orthopaedic reamer
Alliance® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glenoid orthopaedic reamer.
- Equinoxe — Exactech, Inc. · Class II
- LINK Embrace Shoulder System Line Extension — WALDEMAR LINK GmbH & Co. KG · Class I
- PRIMA TT Glenoid — Limacorporate · Class II
- OFF AXIS COMP MINI REAMER 6-SPOKE LG — Biomet Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- Equinoxe — Exactech, Inc. · Class II
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 1cadb1e6-1c5b-4bda-a8a1-fdf68e93999e 35 fields · synced May 30, 2026