Identity
- Trade Name
- FIXED TARGETING INSERT FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- FIXED TARGETING INSERT FDA UDI
- Model / Reference
- 324-0003 FDA UDI
- Description
- FIXED TARGETING INSERT FDA UDI
Identifiers
- Catalog Number
- 324-0003 FDA UDI
- Primary DI / UDI-DI
- 00810189110311 FDA UDI
- 510(k) Number
- K230764 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Surgical drill guide, reusable
Fixed Targeting Insert by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
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- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K230764 also covers:
- 11 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 75mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 80mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 85mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11 X 90mm LAG FASTENER — OsteoCentric Technologies,Inc
- 11mm HALF TAP CANNULATED — OsteoCentric Technologies,Inc
- 13 X 100mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 105mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 110mm LAG FASTENER — OsteoCentric Technologies,Inc
- 13 X 115mm LAG FASTENER — 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 1574fed4-e1fa-483b-b071-1c7b483da71b 36 fields · synced May 30, 2026