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Ø7.0 x 24mm x 45mm CANNULATED PARTIAL THREAD SCREW
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Ø7.0 x 24mm x 45mm CANNULATED PARTIAL THREAD SCREW FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Ø7.0 x 24mm x 45mm CANNULATED PARTIAL THREAD SCREW FDA UDI
- Model / Reference
- 370-5045-024 FDA UDI
- Description
- Ø7.0 x 24mm x 45mm CANNULATED PARTIAL THREAD SCREW FDA UDI
Identifiers
- Catalog Number
- 370-5045-024 FDA UDI
- Primary DI / UDI-DI
- 00816950026683 FDA UDI
- 510(k) Number
- K170021 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
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Ø7.0 x 24mm x 45mm CANNULATED PARTIAL THREAD 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).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 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
K170021 also covers:
- 1.6mm Guide Wire Smooth Trocar 150mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Cann Fixed — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, AO QC Shaft 290mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, Fixed 290mm — OsteoCentric Technologies,Inc
- 2.74mm Guidewire, Threaded Trocar Tip SS, 450mm — OsteoCentric Technologies,Inc
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc
- 2.8 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc
- 2.8/3.5mm Double Drill Guide — OsteoCentric Technologies,Inc
- 4.0 X 105mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 110mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti FL THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti LG THD — 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 7a324cb5-38f3-466f-b70a-f6b793f858ed 37 fields · synced Jun 1, 2026