Identity
- Trade Name
- AO QC Handle FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- AO QC Handle FDA UDI
- Model / Reference
- 110302 FDA UDI
- Description
- AO QC Handle FDA UDI
Identifiers
- Catalog Number
- 110302 FDA UDI
- Primary DI / UDI-DI
- 00816950028199 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
Category: Orthopaedic inorganic implant inserter/extractor, reusable
AO QC Handle by OsteoCentric Technologies, Inc — Class I — 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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- 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 1a376af7-ac92-4590-9851-9049095ab332 36 fields · synced May 30, 2026