Identity
- Trade Name
- COMPREHENSIVE® REVERSE SHOULDER FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 110040010 FDA UDI
Identifiers
- Catalog Number
- 110040010 FDA UDI
- Primary DI / UDI-DI
- 00880304811201 FDA UDI
- 510(k) Number
- K172502 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIKWT FDA UDIPAO FDA UDIMBF FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3670 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: Surgical implant template, reusable
Comprehensive® Reverse Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
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- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K172502 also covers:
- COMPR AUG MINI CPTRD PN PLCMNT GD SM (SUP) — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE® REVERSE SHOULDER — Biomet 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI de4b5438-f753-4beb-a8a0-49236cf321b9 36 fields · synced May 30, 2026