867435

GUDID 10603295217954

UNIVERSAL STEM FLUTED 115mm x 24mm

DEPUY ORTHOPAEDICS, INC.

Knee femur stem prosthesis

• Primary Device ID: 10603295217954
• NIH Device Record Key: a0a1eeef-f721-4d25-a85f-79caf20c68a0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 86-7435
• Catalog Number: 867435
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295217954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063633

FDA Product Code

• NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-03-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295554974 - EMPHASYS: 2026-02-12 EMPHASYS MAKE TO ORDER CUP IMPACTOR WITH STRIKE PLATE 14.5 INCH
• 10603295080121 - AML EXCEL: 2026-02-09 AML EXCEL FEMORAL/HUMERAL HEAD IMPACTOR
• 10603295082408 - DURALOC: 2026-02-09 DURALOC POLY IMPACTOR HANDLE
• 10603295083382 - SIGMA: 2026-02-09 SIGMA HP PARTIAL KNEE-UNI FEMORAL IMPACTOR
• 10603295084075 - SIGMA: 2026-02-09 SIGMA HP PARTIAL KNEE-TROCHLEA IMPACTOR
• 10603295088042 - GLOBAL FX: 2026-02-09 GLOBAL FX HEAD IMPACTION STAND
• 10603295090540 - GLOBAL AP: 2026-02-09 GLOBAL AP TAPER IMPACTOR
• 10603295090687 - GLOBAL AP: 2026-02-09 GLOBAL AP HEAD IMPACTOR