SYNTHES SYNMESH SPACER SYSTEM

Spinal Vertebral Body Replacement Device

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Synmesh Spacer System.

Pre-market Notification Details

Device IDK003275
510k NumberK003275
Device Name:SYNTHES SYNMESH SPACER SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-19
Decision Date2001-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9814956240 K003275 000
H9814956020 K003275 000
H9814956010 K003275 000
H9814954100 K003275 000
10705034817996 K003275 000
10705034817989 K003275 000
10705034817965 K003275 000
10705034817958 K003275 000
10705034817941 K003275 000
10705034817934 K003275 000
H9814956030 K003275 000
H9814956040 K003275 000
H9814956230 K003275 000
H9814956220 K003275 000
H9814956210 K003275 000
H9814956150 K003275 000
H9814956140 K003275 000
H9814956130 K003275 000
H9814956120 K003275 000
H9814956110 K003275 000
H9814956050 K003275 000
10705034817927 K003275 000

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