PELVIC C-CLAMP

Component, Traction, Invasive

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Pelvic C-clamp.

Pre-market Notification Details

Device IDK922796
510k NumberK922796
Device Name:PELVIC C-CLAMP
ClassificationComponent, Traction, Invasive
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 CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-09
Decision Date1994-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679398370 K922796 000

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