AXLE PEEK INTERSPINOUS FUSION SYSTEM

Appliance, Fixation, Spinal Interlaminal

X-SPINE SYSTEMS, INC

The following data is part of a premarket notification filed by X-spine Systems, Inc with the FDA for Axle Peek Interspinous Fusion System.

Pre-market Notification Details

Device IDK112592
510k NumberK112592
Device Name:AXLE PEEK INTERSPINOUS FUSION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg,  OH  45342
ContactDavid Kirschman
CorrespondentDavid Kirschman
X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg,  OH  45342
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-07
Decision Date2011-12-05
Summary:summary

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