PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT

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

SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Profix Plus Tibial Insert, Profix Ps Plus Tibial Insert, Profix P/s Tibial Insert.

Pre-market Notification Details

• Device ID: K963255
• 510k Number: K963255
• Device Name: PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116
• 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: 1996-08-19
• Decision Date: 1997-01-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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