Identity
- Trade Name
- My3D® Personalized Pelvic Reconstruction FDA UDI
- Generic Name
- Screw extractor, reusable FDA UDI
- Device Name
- CONICAL SCREW EXTRACTOR, 4.5 -7.0MM SCREWS, AO CONNECTION FDA UDI
- Model / Reference
- EX-35065-04N FDA UDI
- Description
- CONICAL SCREW EXTRACTOR, 4.5 -7.0MM SCREWS, AO CONNECTION FDA UDI
Identifiers
- Catalog Number
- EX-35065-04N FDA UDI
- Primary DI / UDI-DI
- B278EX3506504N0 FDA UDI
- 510(k) Number
- K212815 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Screw extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Category: Screw extractor, reusable
My3D® Personalized Pelvic Reconstruction by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw extractor, reusable.
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Cleared under the same submission
K212815 also covers:
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, INC.
- My3D® Personalized Pelvic Reconstruction — ONKOS SURGICAL, 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
- Onkos Surgical, Inc.
Sources (1)
- FDA UDI dc64a3e2-b5a5-42d9-b038-0879e2aa4b30 35 fields · synced Jun 8, 2026