SYNTHES CRANIAL FLAP TWIST CLAMP

Plate, Cranioplasty, Preformed, Non-alterable

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Flap Twist Clamp.

Pre-market Notification Details

Device IDK991860
510k NumberK991860
Device Name:SYNTHES CRANIAL FLAP TWIST CLAMP
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-01
Decision Date1999-07-20
Summary:summary

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