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P.f.c. Sigma

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
P.F.C. SIGMA FDA UDI
Generic Name
Tibial insert FDA UDI
Device Name
P.F.C. SIGMA TIBIAL INSERT FIXED BEARING POSTERIOR-LIPPED (PLI) 2 10mm GVF FDA UDI
Model / Reference
1581-01-010 FDA UDI
Description
P.F.C. SIGMA TIBIAL INSERT FIXED BEARING POSTERIOR-LIPPED (PLI) 2 10mm GVF FDA UDI

Identifiers

Catalog Number
158101010 FDA UDI
Primary DI / UDI-DI
10603295062257 FDA UDI
510(k) Number
K033272 FDA UDI
K040166 FDA UDI
K082500 FDA UDI
K241000 FDA UDI
K943462 FDA UDI
K961685 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Tibial insert FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 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
MRI Safety
MR Conditional FDA UDI

Category: Tibial insert

P.f.c. Sigma by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibial insert.

Cleared under the same submission

K033272 also covers:

K040166 also covers:

K082500 also covers:

K241000 also covers:

K943462 also covers:

K961685 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI d1e465b9-ccb9-4f33-82b7-05a2ad4ad80e 36 fields · synced May 30, 2026