Identity
- Trade Name
- Comprehensive FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Model / Reference
- SSI004940 FDA UDI
Identifiers
- Catalog Number
- SSI004940 FDA UDI
- Primary DI / UDI-DI
- 00889024563599 FDA UDI
- 510(k) Number
- K152754 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Comprehensive by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Calibrate — ALPHATEC SPINE, INC. · Class II
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- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
- General Instruments — ALPHATEC SPINE, INC. · Class I
Cleared under the same submission
K152754 also covers:
- COMPREHENSIVE® VRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS HA GLENOID — Biomet Orthopedics, Inc.
- COMPREHENSIVE® VRS INSTRUMENT — Biomet Orthopedics, Inc.
- Comprehensive® Shoulder System — Biomet Orthopedics, Inc.
- Comprehensive® VRS Glenoid — Biomet Orthopedics, Inc.
- Comprehensive® VRS Glenoid — Biomet Orthopedics, Inc.
- Comprehensive® VRS™ — Biomet Orthopedics, Inc.
- Comprehensive® VRS™ Glenoid — 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 c1a11dbb-466d-4ee6-a485-a09c66654874 35 fields · synced May 30, 2026