Identity
- Trade Name
- 5.0 X 120MM TROCAR FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- 5.0 X 120MM TROCAR FDA UDI
- Model / Reference
- 303-5004 FDA UDI
- Description
- 5.0 X 120MM TROCAR FDA UDI
Identifiers
- Catalog Number
- 303-5004 FDA UDI
- Primary DI / UDI-DI
- 00816950029776 FDA UDI
- 510(k) Number
- K160603 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.0 Millimeter FDA UDILength — 120 Millimeter FDA UDI
Category: Surgical drill guide, reusable
5.0 X 120mm Trocar 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
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- 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
K160603 also covers:
- 3.2 X 125MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 4.0 X 105MM SCHANZ PIN FASTENER 45MM THD — OsteoCentric Technologies,Inc
- 4.0 X 125MM TAP — OsteoCentric Technologies,Inc
- 4.0 X 150MM SCHANZ PIN FASTENER 55MM THD — OsteoCentric Technologies,Inc
- 4.0 X 235MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 4.0 X 30MM DRILL SLEEVE — OsteoCentric Technologies,Inc
- 4.0 X 30MM OUTER SLEEVE — OsteoCentric Technologies,Inc
- 4.0 X 30MM TROCAR — OsteoCentric Technologies,Inc
- 4.0 X 95MM SCHANZ PIN FASTENER 35MM THD — OsteoCentric Technologies,Inc
- 4.5 X 235MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 5.0 X 120MM DRILL SLEEVE — OsteoCentric Technologies,Inc
- 5.0 X 120MM OUTER SLEEVE — 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 298b2b7b-38a5-421a-98ac-35cc905d3d8b 37 fields · synced May 30, 2026