SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM

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

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Scorpio Total Stablizer (ts) Total Knee System.

Pre-market Notification Details

• Device ID: K994128
• 510k Number: K994128
• Device Name: SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Terry Sheridan Powell
• Correspondent: Terry Sheridan Powell; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-07
• Decision Date: 2000-03-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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