CASPIAN SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Caspian Spinal System.

Pre-market Notification Details

Device IDK103232
510k NumberK103232
Device Name:CASPIAN SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-02
Decision Date2011-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888857014992 K103232 000
10888857014497 K103232 000
10888857014428 K103232 000
10888857014350 K103232 000
10888857014275 K103232 000
10888857014206 K103232 000
10888857014091 K103232 000
10888857014022 K103232 000
10888857013957 K103232 000
10888857014602 K103232 000
10888857014671 K103232 000
10888857014756 K103232 000
10888857014985 K103232 000
10888857014954 K103232 000
10888857014947 K103232 000
10888857014916 K103232 000
10888857014909 K103232 000
10888857014879 K103232 000
10888857014862 K103232 000
10888857014817 K103232 000
10888857013872 K103232 000
10888857013797 K103232 000
10888857013728 K103232 000
10888857012912 K103232 000
10888857012806 K103232 000
10888857012738 K103232 000
10888857012660 K103232 000
10888857012585 K103232 000
10888857012509 K103232 000
10888857012431 K103232 000
10888857012387 K103232 000
10888857012981 K103232 000
10888857013063 K103232 000
10888857013131 K103232 000
10888857013674 K103232 000
10888857013629 K103232 000
10888857013575 K103232 000
10888857013520 K103232 000
10888857013469 K103232 000
10888857013384 K103232 000
10888857013315 K103232 000
10888857013209 K103232 000
10888857012332 K103232 000
10888857017931 K103232 000
10888857016194 K103232 000
10888857016187 K103232 000
10888857015586 K103232 000
10888857015555 K103232 000
10888857015548 K103232 000
10888857015517 K103232 000
10888857015500 K103232 000
10888857015470 K103232 000
10888857016200 K103232 000
10888857016217 K103232 000
10888857016224 K103232 000
10888857017924 K103232 000
10888857016316 K103232 000
10888857016309 K103232 000
10888857016293 K103232 000
10888857016286 K103232 000
10888857016279 K103232 000
10888857016262 K103232 000
10888857016231 K103232 000
10888857015463 K103232 000
10888857015432 K103232 000
10888857015425 K103232 000
10888857015180 K103232 000
10888857015159 K103232 000
10888857015142 K103232 000
10888857015111 K103232 000
10888857015104 K103232 000
10888857015074 K103232 000
10888857015067 K103232 000
10888857015036 K103232 000
10888857015197 K103232 000
10888857015227 K103232 000
10888857015234 K103232 000
10888857015395 K103232 000
10888857015388 K103232 000
10888857015357 K103232 000
10888857015340 K103232 000
10888857015319 K103232 000
10888857015302 K103232 000
10888857015272 K103232 000
10888857015265 K103232 000
10888857015029 K103232 000

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