SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT

Device, Fixation, Proximal Femoral, Implant

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Limited Contact-dynamic Hip Screw Implant.

Pre-market Notification Details

Device IDK923613
510k NumberK923613
Device Name:SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
ClassificationDevice, Fixation, Proximal Femoral, Implant
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane Cochet-wynant
CorrespondentDiane Cochet-wynant
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeJDO  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-21
Decision Date1993-06-22

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