ATTUNE 151700116

GUDID 10603295054412

ATTUNE KNEE SYSTEM REVISION CRS FIXED BEARING INSERT AOX 16MM SIZE 1

DEPUY (IRELAND)

Tibial insert

• Primary Device ID: 10603295054412
• NIH Device Record Key: 0243717b-d610-49f1-9b41-0e2e284c49ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTUNE
• Version Model Number: 1517-00-116
• Catalog Number: 151700116
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295054412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160700

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

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: 2024-12-09
• Device Publish Date: 2016-12-05

On-Brand Devices [ATTUNE]

• 10603295492023: ATTUNE KNEE SYSTEM REVISION ADAPTOR TRIAL EXTRACTOR
• 10603295478614: ATTUNE KNEE SYSTEM REVISION STEM TRIAL DRIVER BIT
• 10603295451303: ATTUNE KNEE SYSTEM REVISION FEMORAL TRIAL EXTRACTOR
• 10603295440499: ATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE TAPER SEPARATOR DRIVER
• 10603295440482: ATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE TAPER SEPARATOR BASE
• 10603295440451: ATTUNE KNEE SYSTEM REVISION STEM TRIAL AND STABILIZER EXTRACTOR
• 10603295440390: ATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE SEPARATOR PUSH ROD
• 10603295438700: ATTUNE KNEE SYSTEM REVISION TIBIAL BASE TRIAL EXTRACTOR
• 10603295131021: ATTUNE TRIAL EXTRACTOR
• 10603295130215: ATTUNE FEMORAL INTRODUCER
• 10603295482017: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 24MM
• 10603295482000: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 20MM
• 10603295481997: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 18MM
• 10603295481980: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 14MM
• 10603295481973: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 12MM
• 10603295481966: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 10MM
• 10603295481959: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 8MM
• 10603295481942: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 6MM
• 10603295477310: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 26MM
• 10603295477303: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 24MM
• 10603295477297: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 22MM
• 10603295477280: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 20MM
• 10603295477273: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 18MM
• 10603295477266: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 16MM
• 10603295477259: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 14MM
• 10603295477242: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 12MM
• 10603295477235: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 10MM
• 10603295477228: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 8MM
• 10603295477211: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 10 6MM
• 10603295477204: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 26MM
• 10603295477129: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 22MM
• 10603295477112: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 9 16MM
• 10603295476009: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 8MM
• 10603295475996: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 6MM
• 10603295475989: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 14MM
• 10603295475972: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 12MM
• 10603295475965: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 10MM
• 10603295475804: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 22MM
• 10603295475798: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 20MM
• 10603295475781: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 18MM
• 10603295475774: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 16MM
• 10603295475767: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 14MM
• 10603295475750: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 8MM
• 10603295475743: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 6MM
• 10603295475736: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 12MM
• 10603295475729: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 2 10MM
• 10603295475712: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 26MM
• 10603295475705: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 24MM
• 10603295475699: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 22MM
• 10603295475682: ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 1 20MM