Sigma

FDA UDI

Class III (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SIGMA FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 3 20mm GVF FDA UDI
Model / Reference: 96-2345 FDA UDI
Description: SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 3 20mm GVF FDA UDI

Identifiers

Catalog Number: 962345 FDA UDI
Primary DI / UDI-DI: 10603295242260 FDA UDI
FDA Product Code: NJL FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class III 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibial insert

Sigma by Depuy (ireland) — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibial insert.

DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Truliant, Activit-E — Exactech, Inc. · Class II
Maxim Knee System — Biomet Orthopedics, Inc. · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Optetrak Logic — Exactech, Inc. · Class II

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 III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI d82b7788-345a-4ca4-ab3b-889e96cfd6a9 35 fields · synced May 29, 2026