STALIF C FLX, STALIF M FLX, STALIF L FLX And STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX And ACTILIF Lateral-Oblique FLX

Intervertebral Fusion Device With Bone Graft, Lumbar

Centinel Spine, Inc.

The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Stalif C Flx, Stalif M Flx, Stalif L Flx And Stalif Lateral-oblique Flx, Actilif C Flx, Actilif M Flx, Actilif L Flx And Actilif Lateral-oblique Flx.

Pre-market Notification Details

Device IDK173347
510k NumberK173347
Device Name:STALIF C FLX, STALIF M FLX, STALIF L FLX And STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX And ACTILIF Lateral-Oblique FLX
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Centinel Spine, Inc. 900 Airport Road, Suite 3B West Chester,  PA  19380
ContactJessica Staub
CorrespondentJustin Eggleton
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-25
Decision Date2018-05-08
Summary:summary

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