Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage

Spinal Vertebral Body Replacement Device

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Camber Spine Technologies Spira - V™ Open Matrix Corpectomy Cage.

Pre-market Notification Details

Device IDK173800
510k NumberK173800
Device Name:Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
ClassificationSpinal Vertebral Body Replacement Device
Applicant Camber Spine Technologies 418 E. Lancaster Avenue Wayne,  PA  19087
ContactMichael Black
CorrespondentJustin Eggleton
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-14
Decision Date2018-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B030SPV1214535330 K173800 000
B030SPV1214507310 K173800 000
B030SPV1214507290 K173800 000
B030SPV1214507270 K173800 000
B030SPV1214507250 K173800 000
B030SPV1214507230 K173800 000
B030SPV1214507210 K173800 000
B030SPV1214507190 K173800 000
B030SPV1214507170 K173800 000
B030SPV1214507330 K173800 000
B030SPV1214535150 K173800 000
B030SPV1214535310 K173800 000
B030SPV1214535290 K173800 000
B030SPV1214535270 K173800 000
B030SPV1214535250 K173800 000
B030SPV1214535230 K173800 000
B030SPV1214535210 K173800 000
B030SPV1214535190 K173800 000
B030SPV1214535170 K173800 000
B030SPV1214507150 K173800 000

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