KNEE PROSTHESIS-TIBIAL COMPONENT

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 Knee Prosthesis-tibial Component.

Pre-market Notification Details

• Device ID: K830927
• 510k Number: K830927
• Device Name: KNEE PROSTHESIS-TIBIAL COMPONENT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-23
• Decision Date: 1983-07-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295216469	K830927	000
10603295216445	K830927	000
10603295216438	K830927	000
10603295216421	K830927	000
10603295216322	K830927	000
10603295216452	K830927	000