Identity
- Trade Name
- My3D® Personalized Pelvic Reconstruction FDA UDI
- Generic Name
- Acetabulum prosthesis hole plug FDA UDI
- Device Name
- APICAL HOLE PLUG, 3/8-16 TPI, 3.5 HEX, FLAT FDA UDI
- Model / Reference
- AP-38016-04M FDA UDI
- Description
- APICAL HOLE PLUG, 3/8-16 TPI, 3.5 HEX, FLAT FDA UDI
Identifiers
- Primary DI / UDI-DI
- B278AP3801604M0 FDA UDI
- 510(k) Number
- K212815 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabulum prosthesis hole plug 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetabulum prosthesis hole plug
My3D® Personalized Pelvic Reconstruction by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis hole plug.
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- Continuum® — Zimmer, Inc. · Class II
- ORTHOLOC™ 2 Jones Fracture System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Converge® — Zimmer, Inc. · Class II
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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 4c41766c-7d23-4f9f-8344-c51956f2fcb3 34 fields · synced May 29, 2026