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: Surgical implant handling forceps FDA UDI
Device Name: 6.5MM SCREW FORCEPS FDA UDI
Model / Reference: SF-65000-04N FDA UDI
Description: 6.5MM SCREW FORCEPS FDA UDI

Identifiers

Catalog Number: SF-65000-04N FDA UDI
Primary DI / UDI-DI: B278SF6500004N0 FDA UDI
510(k) Number: K212815 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Surgical implant handling forceps 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant handling forceps

My3D® Personalized Pelvic Reconstruction by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EVOLVE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

Cleared under the same submission

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 ff74f791-7b96-4b4c-8bfa-3d11bdb81d0b 35 fields · synced Jun 1, 2026