SIGMA 102411211

GUDID 10603295001904

SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 2 11mm LM/RL XLK

DEPUY (IRELAND)

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 10603295001904
• NIH Device Record Key: 66a9c874-bcc3-43bd-96b5-0bc20456f87f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA
• Version Model Number: 1024-11-211
• Catalog Number: 102411211
• 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	10603295001904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061648

FDA Product Code

• KRR: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, 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: 2015-09-24

On-Brand Devices [SIGMA]

• 10603295074991: SIGMA FEMORAL CR150 CEMENTED SIZE 6 RIGHT
• 10603295074984: SIGMA FEMORAL CR150 CEMENTED SIZE 5 RIGHT
• 10603295074977: SIGMA FEMORAL CR150 CEMENTED SIZE 4N RIGHT
• 10603295074960: SIGMA FEMORAL CR150 CEMENTED SIZE 4 RIGHT
• 10603295074953: SIGMA FEMORAL CR150 CEMENTED SIZE 3 RIGHT
• 10603295074946: SIGMA FEMORAL CR150 CEMENTED SIZE 2.5 RIGHT
• 10603295074922: SIGMA FEMORAL CR150 CEMENTED SIZE 1.5 RIGHT
• 10603295074878: SIGMA FEMORAL CR150 CEMENTED SIZE 4 LEFT
• 10603295074861: SIGMA FEMORAL CR150 CEMENTED SIZE 3 LEFT
• 10603295074854: SIGMA FEMORAL CR150 CEMENTED SIZE 2.5 LEFT
• 10603295074847: SIGMA FEMORAL CR150 CEMENTED SIZE 2 LEFT
• 10603295074830: SIGMA FEMORAL CR150 CEMENTED SIZE 1.5 LEFT
• 10603295074939: SIGMA FEMORAL CR150 CEMENTED SIZE 2 RIGHT
• 10603295074908: SIGMA FEMORAL CR150 CEMENTED SIZE 6 LEFT
• 10603295074892: SIGMA FEMORAL CR150 CEMENTED SIZE 5 LEFT
• 10603295074885: SIGMA FEMORAL CR150 CEMENTED SIZE 4N LEFT
• 10603295327196: SIGMA HP REVISION INSTRUMENTS TC3 RP INSERT TRIAL & SPACER BLOCK CASE
• 10603295081692: SIGMA HP REVISION INSTRUMENTS FEMORAL TRIAL CASE
• 10603295081685: SIGMA HP REVISION INSTRUMENTS FEMORAL PREP CASE
• 10603295502029: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 9MM
• 10603295502012: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 8MM
• 10603295502005: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 7MM
• 10603295501992: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 11MM
• 10603295501985: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 10MM
• 10603295501978: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 9MM
• 10603295501961: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 8MM
• 10603295501954: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 7MM
• 10603295501947: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 11MM
• 10603295501930: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 10MM
• 10603295501923: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4 RM/LL 9MM
• 10603295501916: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4 RM/LL 8MM
• 10603295501909: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4 RM/LL 7MM
• 10603295501893: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4 RM/LL 11MM
• 10603295501886: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 4 RM/LL 10MM
• 10603295501879: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 9MM
• 10603295501862: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 8MM
• 10603295501855: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 7MM
• 10603295501848: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 11MM
• 10603295501831: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 10MM
• 10603295501824: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 9MM
• 10603295501817: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 8MM
• 10603295501800: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 7MM
• 10603295501794: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 11MM
• 10603295501787: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2 RM/LL 10MM
• 10603295501770: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 1 RM/LL 9MM
• 10603295501763: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 1 RM/LL 8MM
• 10603295501756: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 1 RM/LL 11MM
• 10603295501749: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 1 RM/LL 10MM
• 10603295501732: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 1 RM/LL 7MM
• 10603295501725: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 LM/RL 9MM