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Sigma 97-0480

by Depuy (Ireland)

Ref 97-0480Model SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

11 Sep 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776531 Date15 Jul 2026IssuedStatusActive expires 11 Sep 2029
United StatesGUDID listing GUDID Number10603295250722 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776531 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    11 Sep 2029
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sigma
Generic Name
Tibial insert
Device Name
Fixed Bearing Tibial Insert
Model / Ref / Catalog
97-0480, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, 970480
Primary DI / UDI-DI
10603295250722
Basic UDI-DI
0603295a003158J
510(k) Number
FDA Product Code
JWH
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN Term
Tibial insert
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No