Identity
- Trade Name
- 4.5 X 235MM DRILL BIT NO SIDE CUTTING FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- 4.5 X 235MM DRILL BIT NO SIDE CUTTING FDA UDI
- Model / Reference
- 303-4523 FDA UDI
- Description
- 4.5 X 235MM DRILL BIT NO SIDE CUTTING FDA UDI
Identifiers
- Catalog Number
- 303-4523 FDA UDI
- Primary DI / UDI-DI
- 00816950029882 FDA UDI
- 510(k) Number
- K160603 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, 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 — 4.5 Millimeter FDA UDILength — 235 Millimeter FDA UDI
Category: Fluted surgical drill bit, reusable
4.5 X 235mm Drill Bit No Side Cutting by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 5.0 X 120MM DRILL SLEEVE — OsteoCentric Technologies,Inc
- 5.0 X 120MM OUTER SLEEVE — OsteoCentric Technologies,Inc
- 5.0 X 120MM TROCAR — 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 efee101d-13da-4c8e-b89f-472569b8b189 37 fields · synced Jun 8, 2026