P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Cruciate Retaining Knee System (size 1.5).

Pre-market Notification Details

• Device ID: K961685
• 510k Number: K961685
• Device Name: P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: John D Ferros
• Correspondent: John D Ferros; JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-01
• Decision Date: 1996-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295232063	K961685	000
10603295231998	K961685	000
10603295216827	K961685	000
10603295216384	K961685	000
10603295232636	K961685	000
10603295232629	K961685	000
10603295232612	K961685	000
10603295232605	K961685	000