P.F.C. SIGMA 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. Sigma Knee System (size 1.5).

Pre-market Notification Details

• Device ID: K971189
• 510k Number: K971189
• Device Name: P.F.C. SIGMA 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 Ferros
• Correspondent: John 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: 1997-04-01
• Decision Date: 1997-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295232520	K971189	000
10603295234036	K971189	000
10603295234012	K971189	000
10603295233992	K971189	000
10603295233985	K971189	000
10603295233978	K971189	000
10603295233961	K971189	000
10603295233954	K971189	000