MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

Cover, Burr Hole

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) (synthes) Low Profile Neuro System.

Pre-market Notification Details

Device IDK042986
510k NumberK042986
Device Name:MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-29
Decision Date2004-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9804215540 K042986 000
H9804215530 K042986 000

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