SYNFIX-LR SPACER

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SYNTHES SPINE CO.LP

The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synfix-lr Spacer.

Pre-market Notification Details

Device IDK072253
510k NumberK072253
Device Name:SYNFIX-LR SPACER
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-14
Decision Date2007-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H981048022130 K072253 000
H981048022110 K072253 000
H981048022120 K072253 000
H981SD038023310 K072253 000
H981SD038024310 K072253 000
H981SD038024340 K072253 000
H981038024310 K072253 000
H98108802016S0 K072253 000
H98108802017S0 K072253 000
H98108802018S0 K072253 000
H98108802019S0 K072253 000
H981048022100 K072253 000

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