Skip to content

Biolox Delta 1365-36-240

by Depuy Orthopaedics, Inc. EUDAMEDGUDID

Active European Union

Ref 1365-36-240Model BIOLOX Delta 11/13 Taper Femoral Heads - Ceramic

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 Number10603295033592 UDI-DIDate24 Mar 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  • Withdrawn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
Biolox Delta
Generic Name
Ceramic femoral head prosthesis
Device Name
11/13 Taper Femoral Heads - Ceramic
Model / Ref / Catalog
1365-36-240, BIOLOX Delta 11/13 Taper Femoral Heads - Ceramic, 136536240
Primary DI / UDI-DI
10603295033592
Basic UDI-DI
0603295a0027997
FDA Product Code
MRA, LZO
EMDN Code
P090804050201 Ceramic femoral heads, total hip replacement
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class III
Regulation Number
888.3353
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ceramic femoral head prosthesis

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

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