Identity
- Trade Name
- 15mm Integrated Hip Fastener 105mm FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 15mm Integrated Hip Fastener 105mm FDA UDI
- Model / Reference
- 317-20105 FDA UDI
- Description
- 15mm Integrated Hip Fastener 105mm FDA UDI
Identifiers
- Catalog Number
- 317-20105 FDA UDI
- Primary DI / UDI-DI
- 00816950028793 FDA UDI
- 510(k) Number
- K210247 FDA UDI
- FDA Product Code
- JDO FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
- Outer Diameter — 15 Millimeter FDA UDILength — 105 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
15mm Integrated Hip Fastener 105mm 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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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
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- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K210247 also covers:
- 13.0mm Tap Cannulated — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 105mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 110mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 80mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 2.0 x 130mm Drill Bit Calibrated — OsteoCentric Technologies,Inc
- 3.2mm Drill Guide — 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 908bd3ce-439c-4dae-a30b-a3efdfe0da23 37 fields · synced May 29, 2026