PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS

Appliance, Fixation, Spinal Intervertebral Body

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Pyrenees Cervical Plate System, Semi-constrained Screws.

Pre-market Notification Details

Device IDK092474
510k NumberK092474
Device Name:PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
ContactRichard W Woods
CorrespondentRichard W Woods
K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-12
Decision Date2010-03-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888857026865 K092474 000
10888857026643 K092474 000
10888857026650 K092474 000
10888857026667 K092474 000
10888857026674 K092474 000
10888857026681 K092474 000
10888857026698 K092474 000
10888857026704 K092474 000
10888857026766 K092474 000
10888857026773 K092474 000
10888857026780 K092474 000
10888857026797 K092474 000
10888857026827 K092474 000
10888857026834 K092474 000
10888857026841 K092474 000
10888857026858 K092474 000
10888857026636 K092474 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.