P.F.C. 860123

GUDID 10603295215448

P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 3 CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 10603295215448
• NIH Device Record Key: dcca5200-8bed-41fb-8b3b-49abdab8c18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C.
• Version Model Number: 86-0123
• Catalog Number: 860123
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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
• 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	10603295215448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241000
• Premarket Notification: K884796

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: 2019-12-11
• Device Publish Date: 2015-09-24

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

• 10603295216766: P.F.C. PRESS FIT REAMER EXTRACTOR
• 10603295216513: P.F.C. TIBIAL INSERT EXTRACTOR
• 10603295211938: P.F.C. BROACH EXTRACTOR
• 10603295218203: P.F.C. DRILL 5/16 in
• 10603295252023: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 1.5 RM/LL CEMENTED
• 10603295252016: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 5 RM/LL CEMENTED
• 10603295252009: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 4 RM/LL CEMENTED
• 10603295251996: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 3 RM/LL CEMENTED
• 10603295251989: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 2 RM/LL CEMENTED
• 10603295251767: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 2.5 LM/RL CEMENTED
• 10603295251743: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 5 LM/RL CEMENTED
• 10603295251729: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 3 LM/RL CEMENTED
• 10603295251712: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 2 LM/RL CEMENTED
• 10603295216322: P.F.C. NON-POROUS KEEL TIBIAL TRAY SZ 1 58mm M/L 38mm A/P
• 10603295215479: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 1.5 CEMENTED
• 10603295215462: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 5 CEMENTED
• 10603295215455: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 4 CEMENTED
• 10603295215448: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 3 CEMENTED
• 10603295215431: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 2 CEMENTED
• 10603295252030: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 2.5 RM/LL CEMENTED
• 10603295251750: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 1.5 LM/RL CEMENTED
• 10603295251736: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS OFFSET 4 LM/RL CEMENTED
• 10603295215486: P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 2.5 CEMENTED
• 10603295252054: P.F.C. OFFSET TIB TALL DRILL BUSH SIZE 4 - 5
• 10603295252047: P.F.C. OFFSET TIB TALL DRILL BUSH SIZE 1.5 - 3
• 10603295216728: P.F.C. TIBIAL TRAY HOLDING CLAMP
• 10603295216544: P.F.C. FEMORAL DRILL GUIDE MODIFIED SZ 3
• 10603295216926: P.F.C. TIBIAL STEM CEMENTED 15mm x 60mm 4/5/6
• 10603295216919: P.F.C. TIBIAL STEM CEMENTED 15mm x 30mm 4/5/6
• 10603295216643: P.F.C. CENTRAL PEG PATELLAR DRILL
• 10603295216476: P.F.C. DRILL BIT AND STEINMAN PIN PACKET (1 UNIT) .125in DIA 5in LGTH
• 10603295207122: P.F.C. GENERIC INSTRUMENT TRAY
• 10603295216520: P.F.C. BONE FILE
• 10603295252153: P.F.C. OFFSET TIB TRAY TRIAL SIZE 5
• 10603295252146: P.F.C. OFFSET TIB TRAY TRIAL SIZE 4
• 10603295252139: P.F.C. OFFSET TIB TRAY TRIAL SIZE 3
• 10603295252122: P.F.C. OFFSET TIB TRAY TRIAL SIZE 2.5
• 10603295252115: P.F.C. OFFSET TIB TRAY TRIAL SIZE 2
• 10603295252108: P.F.C. OFFSET TIB TRAY TRIAL SIZE 1.5
• 10603295217794: P.F.C. TIBIAL FLUTED ROD TRIAL 24mm x 150mm
• 10603295217787: P.F.C. TIBIAL FLUTED ROD TRIAL 22mm x 150mm
• 10603295217770: P.F.C. TIBIAL FLUTED ROD TRIAL 20mm x 150mm
• 10603295217763: P.F.C. TIBIAL FLUTED ROD TRIAL 18mm x 150mm
• 10603295217756: P.F.C. TIBIAL FLUTED ROD TRIAL 16mm x 150mm
• 10603295217749: P.F.C. TIBIAL FLUTED ROD TRIAL 14mm x 150mm
• 10603295217732: P.F.C. TIBIAL FLUTED ROD TRIAL 12mm x 150mm
• 10603295217725: P.F.C. TIBIAL FLUTED ROD TRIAL 10mm x 150mm
• 10603295217718: P.F.C. TIBIAL FLUTED ROD TRIAL 24mm x 115mm
• 10603295217701: P.F.C. TIBIAL FLUTED ROD TRIAL 22mm x 115mm
• 10603295217688: P.F.C. TIBIAL FLUTED ROD TRIAL 18mm x 115mm