INNESIS PEEK TL CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

BK MEDITECH CO., LTD.

The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Innesis Peek Tl Cage.

Pre-market Notification Details

Device IDK140577
510k NumberK140577
Device Name:INNESIS PEEK TL CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant BK MEDITECH CO., LTD. PO BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
BK MEDITECH CO., LTD. PO BOX 560 Stillwater,  MN  55082
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-06
Decision Date2014-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809228124404 K140577 000
08809228124213 K140577 000
08809228124206 K140577 000
08809228124190 K140577 000
08809228124183 K140577 000
08809228124176 K140577 000
08809228124169 K140577 000
08809228124152 K140577 000
08809228124145 K140577 000
08809228124138 K140577 000
08809228124121 K140577 000
08809228124114 K140577 000
08809228124107 K140577 000
08809228124091 K140577 000
08809228124084 K140577 000
08809228124077 K140577 000
08809228124060 K140577 000
08809228124220 K140577 000
08809228124237 K140577 000
08809228124398 K140577 000
08809228124381 K140577 000
08809228124374 K140577 000
08809228124367 K140577 000
08809228124350 K140577 000
08809228124343 K140577 000
08809228124336 K140577 000
08809228124329 K140577 000
08809228124312 K140577 000
08809228124305 K140577 000
08809228124299 K140577 000
08809228124282 K140577 000
08809228124275 K140577 000
08809228124268 K140577 000
08809228124251 K140577 000
08809228124244 K140577 000
08809228124053 K140577 000

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