136553000

GUDID 10603295033950

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +8.5

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295033950
NIH Device Record Keyc5788e4f-32df-4585-8241-974dd550b27b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1365-53-000
Catalog Number136553000
Company DUNS989365556
Company NameDEPUY (IRELAND)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295033950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-09-24

Devices Manufactured by DEPUY (IRELAND)

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10603295503378 - ATTUNE2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +20mm Sz 9/6 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
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