P.F.C. 860383

GUDID 10603295216100

P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2.5 15 DEGREE 21mm

DEPUY (IRELAND)

Knee arthroplasty wedge

• Primary Device ID: 10603295216100
• NIH Device Record Key: b5db539f-2d67-4009-8f97-74cf43035eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C.
• Version Model Number: 86-0383
• Catalog Number: 860383
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295216100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241000

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: 5
• Public Version Date: 2024-12-12
• Device Publish Date: 2015-09-24

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

• 10603295216094: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2.5 10 DEGREE 16mm
• 10603295216087: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 2.5 15mm
• 10603295216070: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 2.5 10mm
• 10603295216063: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 2.5 20 DEGREE 13.5mm
• 10603295216056: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 2.5 10 DEGREE 8mm
• 10603295216049: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 1.5 15 DEGREE 20mm
• 10603295216025: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 1.5 15mm
• 10603295216018: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 1.5 10mm
• 10603295216001: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 1.5 20 DEGREE 12.5mm
• 10603295215998: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 1.5 10 DEGREE 7.5mm
• 10603295215721: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 5 15 DEGREE 24mm
• 10603295215714: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 5 10 DEGREE 18mm
• 10603295215707: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 5 15mm
• 10603295215691: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 5 10mm
• 10603295215684: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 5 20 DEGREE 16.5mm
• 10603295215677: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 5 10 DEGREE 9.5mm
• 10603295215660: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 4 15 DEGREE 23mm
• 10603295215653: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 4 10 DEGREE 17mm
• 10603295215646: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 4 15mm
• 10603295215639: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 4 10mm
• 10603295215622: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 4 20 DEGREE 15mm
• 10603295215615: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 4 10 DEGREE 9mm
• 10603295215608: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 3 15 DEGREE 21.5mm
• 10603295215592: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 3 10 DEGREE 16mm
• 10603295215585: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 3 15mm
• 10603295215578: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 3 10mm
• 10603295215561: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 3 20 DEGREE 14.5mm
• 10603295215554: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 3 10 DEGREE 8.5mm
• 10603295215547: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2 15 DEGREE 20mm
• 10603295215530: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2 10 DEGREE 15mm
• 10603295215523: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 2 15mm
• 10603295215516: P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED 2 10mm
• 10603295215509: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 2 20 DEGREE 13mm
• 10603295215493: P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED 2 10 DEGREE 8mm
• 10603295216100: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2.5 15 DEGREE 21mm
• 10603295216032: P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 1.5 10 DEGREE 15mm