101480790

GUDID 10603295001317

BANTAM FEMORAL HEAD Diameter 28mm +5 10/12 TAPER

DEPUY ORTHOPAEDICS, INC.

Metallic femoral head prosthesis
Primary Device ID10603295001317
NIH Device Record Key621efa93-4f43-4386-86d2-a442ec06b6fb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1014-80-790
Catalog Number101480790
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
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
GS110603295001317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

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 ORTHOPAEDICS, INC.

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10603295549031 - SIGMA2025-04-10 SIGMA MAKE TO ORDER HP 5 DEGREE TIBIAL CUTTING BLOCK LEFT
10603295552673 - ATTUNE2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 29mm
10603295552697 - ATTUNE2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 41mm
10603295552710 - ATTUNE2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 32mm
10603295552796 - ATTUNE2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 35mm
10603295552802 - ATTUNE2025-04-01 ATTUNE MAKE TO ORDER PATELLA MED DOME DRILL TRIAL 38mm
10603295555476 - ATTUNE2025-04-01 ATTUNE TM MAKE TO ORDER CLASSIC SLAP HAMMER ASSEMBLY

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