Identity
- Trade Name
- Comprehensive FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Model / Reference
- 110040239 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024681934 FDA UDI
- FDA Product Code
- KWT FDA UDIPHX FDA UDIKWS FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 FDA UDI888.3660 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 inorganic implant inserter/extractor, reusable
Comprehensive by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
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- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K233148 also covers:
K241043 also covers:
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
- Zimmer, Inc.
Sources (1)
- FDA UDI 2ca4bf9c-3857-4ae4-8d4d-226cf851f5e4 33 fields · synced Jun 8, 2026