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Pinnacle 1219-28-458

by Depuy Orthopaedics, Inc. EUDAMEDGUDID

Active European Union

Ref 1219-28-458Model PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029
United StatesGUDID listing GUDID Number10603295013808 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776549 Active Supplemented

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    30 Jun 2026
    Expires
    4 Jun 2029
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Pinnacle
Generic Name
Non-constrained polyethylene acetabular liner
Device Name
Acetabular Liners - MARATHON UHMWPE
Model / Ref / Catalog
1219-28-458, PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE, 121928458
Primary DI / UDI-DI
10603295013808
Basic UDI-DI
0603295a002758X
FDA Product Code
LPH
EMDN Code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3358
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

Related devices

Category: Non-constrained polyethylene acetabular liner

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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