DURACON CONSTRAINED POSTERIOR STABILIZED (PS) 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 Duracon Constrained Posterior Stabilized (ps) Tibial Insert.

Pre-market Notification Details

• Device ID: K012776
• 510k Number: K012776
• Device Name: DURACON CONSTRAINED POSTERIOR STABILIZED (PS) 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: Margaret F Crowe
• Correspondent: Margaret F Crowe; 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: 2001-08-20
• Decision Date: 2001-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613153133056	K012776	000
07613153132882	K012776	000
07613153132875	K012776	000
07613153132868	K012776	000
07613153132851	K012776	000
07613153132844	K012776	000
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07613153132820	K012776	000
07613153132813	K012776	000
07613153132806	K012776	000
07613153132790	K012776	000
07613153132783	K012776	000
07613153132776	K012776	000
07613153132769	K012776	000
07613153132752	K012776	000
07613153132899	K012776	000
07613153132905	K012776	000
07613153133049	K012776	000
07613153133032	K012776	000
07613153133025	K012776	000
07613153133018	K012776	000
07613153133001	K012776	000
07613153132998	K012776	000
07613153132981	K012776	000
07613153132974	K012776	000
07613153132967	K012776	000
07613153132950	K012776	000
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07613153132936	K012776	000
07613153132929	K012776	000
07613153132912	K012776	000
07613153132745	K012776	000