Identity
- Trade Name
- Comprehensive® Shoulder System FDA UDI
- Generic Name
- Orthopaedic osteotome blade, reusable FDA UDI
- Model / Reference
- 31-406991 FDA UDI
Identifiers
- Catalog Number
- 31-406991 FDA UDI
- Primary DI / UDI-DI
- 00887868479762 FDA UDI
- 510(k) Number
- K182516 FDA UDI
- FDA Product Code
- PKC FDA UDI
- GMDN Term
- Orthopaedic osteotome blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic osteotome blade, reusable
Comprehensive® Shoulder System by Biomet Orthopedics, 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
- RP Medical — Rp Medical, Inc. · Class I
- Identity™ — Zimmer, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- TC-100 — Smith & Nephew, Inc. · Class II
- ARTHROSCOPIC SCALPEL KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- SHORT ACETABULAR BLADE D46 mm SHORT — HPF SRL · Class I
Cleared under the same submission
K182516 also covers:
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — 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 32046984-c14d-4459-a3c0-71139641a4f4 35 fields · synced May 30, 2026