DARWIN KNEE SYSTEM

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 Darwin Knee System.

Pre-market Notification Details

• Device ID: K943462
• 510k Number: K943462
• Device Name: DARWIN KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: JOHNSON & JOHNSON PROFESSIONALS, INC. ORTHOPEDIC DIVISION 325 PARAMOUNT DRIVE Raynham, MA 02767 -0350
• Contact: John D Ferros
• Correspondent: John D Ferros; JOHNSON & JOHNSON PROFESSIONALS, INC. ORTHOPEDIC DIVISION 325 PARAMOUNT DRIVE Raynham, MA 02767 -0350
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-18
• Decision Date: 1994-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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