INNESIS PEEK CERVICAL CAGE

Intervertebral Fusion Device With Bone Graft, Cervical

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 Cervical Cage.

Pre-market Notification Details

Device IDK132483
510k NumberK132483
Device Name:INNESIS PEEK CERVICAL CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
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 CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-08
Decision Date2014-04-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809228122523 K132483 000
08809228122424 K132483 000
08809228122431 K132483 000
08809228122448 K132483 000
08809228122455 K132483 000
08809228122462 K132483 000
08809228122479 K132483 000
08809228122486 K132483 000
08809228122493 K132483 000
08809228122509 K132483 000
08809228122516 K132483 000
08809228122417 K132483 000

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