Identity
- Trade Name
- SMV Interlocking Schanz Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 145mm, 5.0mm SMV Interlocking Schanz Screw, Self-Tapping FDA UDI
- Model / Reference
- 350-4145 FDA UDI
- Description
- 145mm, 5.0mm SMV Interlocking Schanz Screw, Self-Tapping FDA UDI
Identifiers
- Catalog Number
- 350-4145 FDA UDI
- Primary DI / UDI-DI
- 00816950021688 FDA UDI
- 510(k) Number
- K160603 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
- Length — 145 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
SMV Interlocking Schanz Screw by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 76e9b487-420c-44bf-9eaf-2cce2808ff2f 37 fields · synced May 30, 2026