Identity
- Trade Name
- COMPREHENSIVE SHOULDER FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Model / Reference
- 110005281 FDA UDI
Identifiers
- Catalog Number
- 110005281 FDA UDI
- Primary DI / UDI-DI
- 00880304568112 FDA UDI
- 510(k) Number
- K130390 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIMBF FDA UDIKWT FDA UDIPAO FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3650 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, reusable
Comprehensive Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
- Truliant CC — Exactech, Inc. · Class II
- Adaptor Delta Cups — Limacorporate · Class II
- Jet-X — Smith & Nephew, Inc. · Class II
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- ACS® — implantcast GmbH · Class I
- Shukla Copter S9COPTER — Shukla Medical · Class I
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- PB Uni tibial impaction adapter — implantcast GmbH · Class I
Cleared under the same submission
K130390 also covers:
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — 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 68beb2c6-e9f2-4fa7-840f-a0213f62d7aa 36 fields · synced May 30, 2026