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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
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
3.2 x 89MM Smooth Trocar Tip Pin FDA UDI
Model / Reference
PN-32089-04N FDA UDI
Description
3.2 x 89MM Smooth Trocar Tip Pin FDA UDI

Identifiers

Catalog Number
PN-32089-04N FDA UDI
Primary DI / UDI-DI
B278PN3208904N0 FDA UDI
FDA Product Code
LPH FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, 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: Intraoperative orthopaedic bone pin/screw, single-use

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 Intraoperative orthopaedic bone pin/screw, single-use.

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 f40f3a2a-7a54-42b2-ad38-d70237085f9a 34 fields · synced Jun 8, 2026