136553000

GUDID 10603295033950

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

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295033950
• NIH Device Record Key: c5788e4f-32df-4585-8241-974dd550b27b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1365-53-000
• Catalog Number: 136553000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295033950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980513

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)

• 10603295098096 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 49mm OD
• 10603295098102 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 53mm OD
• 10603295098119 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 57mm OD
• 10603295098126 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 61mm OD
• 10603295098133 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 65mm OD
• 10603295098140 - PINNACLE GRIPTION TF: 2024-12-13 PINNACLE GRIPTION TF HALF SHELL TRIAL 69mm OD
• 10603295133223 - ATTUNE: 2024-12-13 ATTUNE RP TRIAL POST
• 10603295001652 - SIGMA: 2024-12-12 SIGMA HIGH PERFORMANCE PARTIAL KNEE PFJ TROCHLEA SIZE 5 LEFT CEMENTED