Identity
- Trade Name
- My3D® Personalized Pelvic Reconstruction FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- 4.3 x 50MM Modular Drill Bit FDA UDI
- Model / Reference
- DR-43050-04N FDA UDI
- Description
- 4.3 x 50MM Modular Drill Bit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B278DR4305004N0 FDA UDI
- 510(k) Number
- K212815 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fluted surgical drill bit, single-use
My3D® Personalized Pelvic Reconstruction by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 b8ecd18a-1e36-4a26-9ff3-5afa29f71d22 34 fields · synced May 30, 2026