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My3D® Personalized Pelvic Reconstruction

FDA UDI

Class II (US FDA UDI)

by Onkos Surgical, Inc.

Identity

Trade Name
My3D® Personalized Pelvic Reconstruction FDA UDI
Generic Name
Combination-material acetabulum prosthesis FDA UDI
Device Name
Advanced Pelvic Reconstruction Implant FDA UDI
Model / Reference
PV-APRCN-04M FDA UDI
Description
Advanced Pelvic Reconstruction Implant FDA UDI

Identifiers

Catalog Number
PV-APRCN-04M FDA UDI
Primary DI / UDI-DI
B278PVAPRCN04M0 FDA UDI
510(k) Number
K212815 FDA UDI
FDA Product Code
LPH FDA UDI
GMDN Term
Combination-material acetabulum prosthesis 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Combination-material acetabulum prosthesis

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 Combination-material acetabulum prosthesis.

Cleared under the same submission

K212815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Onkos Surgical, Inc.

Sources (1)

  • FDA UDI 564b6a15-52d0-44bb-bdb1-2a241d6aacf9 35 fields · synced Jun 1, 2026