101836511

GUDID 10603295001409

M-SPEC METAL FEMORAL HEAD 14/16 TAPER Diameter 36mm +11 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295001409
• NIH Device Record Key: c1f8d23e-b188-4843-b698-4693a62fae5f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1018-36-511
• Catalog Number: 101836511
• 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	10603295001409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120599

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)

• 10603295543879 - RECLAIM: 2026-02-02 RECLAIM MONOBLOC REVISION HIP SYSTEM MONOBLOC X-RAY TEMPLATE 115% K
• 10603295543916 - RECLAIM: 2026-02-02 RECLAIM MONOBLOC REVISION HIP SYSTEM MONOBLOC X-RAY TEMPLATE 120% K
• 10603295503309 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +10mm Sz 3/1 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
• 10603295503316 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +20mm Sz 3/1 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
• 10603295503323 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +10mm Sz 5/3 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
• 10603295503330 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +20mm Sz 5/2 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
• 10603295503347 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +10mm Sz 7/5 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY
• 10603295503354 - ATTUNE: 2026-01-21 Attune Knee System Revision Thick Tibial Base Rotating Platform +20mm Sz 7/4 CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY