SCORPIO CR SUPERFLEX TIBIAL INSERT

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 Cr Superflex Tibial Insert.

Pre-market Notification Details

• Device ID: K011643
• 510k Number: K011643
• Device Name: SCORPIO CR SUPERFLEX TIBIAL INSERT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Mary-catherine Dillon
• Correspondent: Mary-catherine Dillon; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-29
• Decision Date: 2001-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613154020775	K011643	000
07613154020577	K011643	000
07613154020560	K011643	000
07613154020553	K011643	000
07613154020546	K011643	000
07613154020539	K011643	000
07613154020522	K011643	000
07613154020515	K011643	000
07613154020508	K011643	000
07613154020492	K011643	000
07613154020485	K011643	000
07613154020478	K011643	000
07613154020461	K011643	000
07613154020454	K011643	000
07613154020447	K011643	000
07613154020430	K011643	000
07613154020584	K011643	000
07613154020591	K011643	000
07613154020607	K011643	000
07613154020768	K011643	000
07613154020751	K011643	000
07613154020744	K011643	000
07613154020737	K011643	000
07613154020720	K011643	000
07613154020713	K011643	000
07613154020690	K011643	000
07613154020683	K011643	000
07613154020676	K011643	000
07613154020669	K011643	000
07613154020652	K011643	000
07613154020645	K011643	000
07613154020638	K011643	000
07613154020621	K011643	000
07613154020614	K011643	000
07613154020423	K011643	000