P.F.C. SIGMA 158111008

GUDID 10603295063087

P.F.C. SIGMA TIBIAL INSERT FIXED BEARING CURVED 2 8mm GVF

DEPUY (IRELAND)

Tibial insert

• Primary Device ID: 10603295063087
• NIH Device Record Key: becceb9d-fc7f-4bf3-8fc5-0d54c9d89f80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C. SIGMA
• Version Model Number: 1581-11-008
• Catalog Number: 158111008
• 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	10603295063087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033272

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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: 2015-09-24

On-Brand Devices [P.F.C. SIGMA]

• 10603295244462: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 30mm
• 10603295244455: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 25mm
• 10603295244448: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 22.5mm
• 10603295244431: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 20mm
• 10603295244417: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 15mm
• 10603295244394: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 6 10mm
• 10603295244387: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 30mm
• 10603295244370: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 25mm
• 10603295244363: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 22.5mm
• 10603295244356: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 20mm
• 10603295244349: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 17.5mm
• 10603295244332: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 15mm
• 10603295244318: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 12.5mm
• 10603295244301: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 5 10mm
• 10603295244288: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 30mm
• 10603295244264: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 22.5mm
• 10603295244257: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 20mm
• 10603295244240: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 17.5mm
• 10603295244233: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 15mm
• 10603295244226: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 12.5mm
• 10603295244202: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 4 10mm
• 10603295244165: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 30mm
• 10603295244141: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 25mm
• 10603295244127: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 22.5mm
• 10603295244103: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 20mm
• 10603295244097: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 17.5mm
• 10603295244080: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 15mm
• 10603295244066: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 12.5mm
• 10603295244042: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 3 10mm
• 10603295244035: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 30mm
• 10603295244028: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 25mm
• 10603295244011: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 22.5mm
• 10603295244004: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 20mm
• 10603295243984: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 15mm
• 10603295243977: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 12.5mm
• 10603295243960: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2.5 10mm
• 10603295243953: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 30mm
• 10603295243946: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 25mm
• 10603295243939: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 22.5mm
• 10603295243922: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 20mm
• 10603295243915: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 17.5mm
• 10603295243908: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 15mm
• 10603295243892: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 12.5mm
• 10603295243885: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 2 10mm
• 10603295243878: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 30mm
• 10603295243861: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 1.5 25mm
• 10603295243854: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 1.5 22.5mm
• 10603295243847: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 1.5 20.0mm
• 10603295243830: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 1.5 17.5mm
• 10603295243823: P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED PLUS 1.5 15mm