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2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length FDA UDI
- Model / Reference
- Ti-1242.22S FDA UDI
- Description
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08903993538906 FDA UDI
- 510(k) Number
- K211324 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length by Auxein Medical Private Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- 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
K211324 also covers:
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 10mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 12mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 18mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 22mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 8mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 14mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 20mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 26mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 28mm length — Auxein Medical Private Limited
- 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right), 3 hole — Auxein Medical Private Limited
- 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left), 4 holes — Auxein Medical Private Limited
- 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left), 5 holes — Auxein Medical Private Limited
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
- Auxein Medical Private Limited
Sources (1)
- FDA UDI fe3a1bf5-27cc-4f0f-b5f8-f78288326eea 35 fields · synced Jun 8, 2026