136561000

GUDID 10603295034032

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 44mm +1.5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295034032
• NIH Device Record Key: f872161a-0429-428b-9e01-137c2eeed067
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1365-61-000
• Catalog Number: 136561000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295034032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060031

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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: 2020-04-06
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY (IRELAND)

• 10603295550389 - INHANCE: 2025-03-24 INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate SMALL Ø24mm CEMENTLESS
• 10603295550396 - INHANCE: 2025-03-24 INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate LARGE Ø29mm CEMENTLESS
• 10603295551768 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM READY-SET GO GENERAL KIT NA NA
• 10603295551829 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM TAPER AND SHELL EXTRACTOR TIP NA NA
• 10603295551836 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM GLENOSPHERE EXTRACTOR TIP NA NA
• 10603295551850 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT MEDIUM NA
• 10603295551867 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT SMALL NA
• 10603295551881 - INHANCE SHOULDER SYSTEM: 2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT EXTRA SMALL NA