Identity
- Trade Name
- UNIVERSAL CHUCK T HANDLE FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- UNIVERSAL CHUCK T HANDLE FDA UDI
- Model / Reference
- 110350 FDA UDI
- Description
- UNIVERSAL CHUCK T HANDLE FDA UDI
Identifiers
- Catalog Number
- 110350 FDA UDI
- Primary DI / UDI-DI
- 00816950029943 FDA UDI
- 510(k) Number
- K152000 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6.0 Millimeter FDA UDILength — 250 Millimeter FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Universal Chuck T Handle by OsteoCentric Technologies, Inc — Class I — 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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- 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
K152000 also covers:
- 1.5Nm Torque Limiter, AO — OsteoCentric Technologies,Inc
- 2.0mm Drill Bit 100mm — OsteoCentric Technologies,Inc
- 2.0mm Drill Bit Calibrated 110mm — OsteoCentric Technologies,Inc
- 2.0mm Drill Calibrated 145mm — OsteoCentric Technologies,Inc
- 2.0mm Threaded Drill Guide Calibrated — OsteoCentric Technologies,Inc
- 2.5 Hex Driver Long — OsteoCentric Technologies,Inc
- 2.5mm Drill Bit 180mm — OsteoCentric Technologies,Inc
- 2.5mm Drill Bit Calibrated 200mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Fixed 300mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Fixed Silicon Handle — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Sleeve — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver w/AO Adapter — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 6c1666e6-8802-43e4-b8df-ba3fc1f3b054 37 fields · synced Jun 8, 2026