SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

Cover, Burr Hole

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK041611
510k NumberK041611
Device Name:SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
ClassificationCover, Burr Hole
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeGXR  
CFR Regulation Number882.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-15
Decision Date2004-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98085180101S0 K041611 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.