BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Bridgepoint Spinous Process Camp- Posterior Fixation System.

Pre-market Notification Details

Device IDK103205
510k NumberK103205
Device Name:BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
ContactOlga Lewis
CorrespondentOlga Lewis
ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-01
Decision Date2011-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844856059191 K103205 000
00844856059184 K103205 000
00844856059177 K103205 000

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