Identity
- Trade Name
- TAPER ADAPTOR REMOVAL TOOL FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Model / Reference
- 110005232 FDA UDI
Identifiers
- Catalog Number
- 110005232 FDA UDI
- Primary DI / UDI-DI
- 00880304537392 FDA UDI
- FDA Product Code
- MAY FDA UDILZO FDA UDILWJ FDA UDIJDI FDA UDILPH FDA UDIKWA FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3350 FDA UDI888.3358 FDA UDI888.3330 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 inorganic implant inserter/extractor, reusable
Taper Adaptor Removal Tool 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.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- Made-To-Order — TORNIER, INC. · Class I
- 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
K061423 also covers:
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- M2A - MODULAR HEAD HIP SYSTEM — Biomet Orthopedics, Inc.
- Universal Taper Adaptor Removal Tool — Biomet Orthopedics, Inc.
K082996 also covers:
- BIOLOX DELTA HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX DELTA HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX DELTA HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX DELTA OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc.
K093549 also covers:
- BIOLOX DELTA HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOLOX® Delta Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip System — Biomet Orthopedics, Inc.
- RingLoc Hip 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 4388ceed-c0b2-4098-8cc0-976562e8bb63 35 fields · synced May 30, 2026