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P.f.c. Sigma

FDA UDI

Class I (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
P.F.C. SIGMA FDA UDI
Generic Name
Orthopaedic bone bolt FDA UDI
Device Name
P.F.C. SIGMA FEMORAL STEM BOLT TRIAL FDA UDI
Model / Reference
96-0762 FDA UDI
Description
P.F.C. SIGMA FEMORAL STEM BOLT TRIAL FDA UDI

Identifiers

Catalog Number
960762 FDA UDI
Primary DI / UDI-DI
10603295233879 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Orthopaedic bone bolt FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone bolt

P.f.c. Sigma by Depuy Orthopaedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone bolt.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI a84a64df-5f05-4c96-96d9-0dfa6a5cb4d1 35 fields · synced Jun 8, 2026