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Pinnacle Porocoat 1217-01-058

by Depuy Orthopaedics, Inc.

Ref 1217-01-058Model PINNACLE Acetabular Shells - POROCOAT Coated

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

CE MDR

Valid until

4 Jun 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029
United StatesGUDID listing GUDID Number10603295008583 UDI-DIDate24 Mar 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776549 Active Supplemented

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    4 Jun 2029
    Reason
    Change approved

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  • Withdrawn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
Pinnacle EUDAMED
Pinnacle Porocoat GUDID
Generic Name
Acetabular shell
Device Name
Acetabular Shells - POROCOAT Coated
Model / Ref / Catalog
1217-01-058, PINNACLE Acetabular Shells - POROCOAT Coated, 121701058
Primary DI / UDI-DI
10603295008583
Basic UDI-DI
0603295a002708M
FDA Product Code
MRA, LPH
EMDN Code
P090803010201, P0908030302
GMDN Term
Acetabular shell
Device Class
Class III
Regulation Number
888.3358
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Depuy Orthopaedics, Inc.

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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