101480789

GUDID 10603295001300

BANTAM FEMORAL HEAD Diameter 28mm +0 10/12 TAPER

DEPUY ORTHOPAEDICS, INC.

Metallic femoral head prosthesis
Primary Device ID10603295001300
NIH Device Record Key4341f16b-fb33-49f8-81be-5891558816be
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1014-80-789
Catalog Number101480789
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
GS110603295001300 [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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10603295499855 - ATTUNE2025-02-21 ATTUNE MAKE TO ORDER BALANCED A/P CHAMFER CUT BLOCK Size 2
10603295094081 - NA2025-01-10 M.B.T. EVALUATION BULLET W/PEGS SIZE 1-3
10603295094098 - NA2025-01-10 M.B.T. EVALUATION BULLET W/PEGS SIZE 4-7
10603295094111 - NA2025-01-10 M.B.T. EVALUATION BULLET W/O PEGS SIZE 1-3
10603295094128 - NA2025-01-10 M.B.T. EVALUATION BULLET W/O PEGS SIZE 4-7
10603295215738 - P.F.C.2025-01-10 P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 2 10 DEG
10603295215745 - P.F.C.2025-01-10 P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 2 20 DEG

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