ACCULIF TL AND PL CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

COALIGN INNOVATIONS, INC.

The following data is part of a premarket notification filed by Coalign Innovations, Inc. with the FDA for Acculif Tl And Pl Cage.

Pre-market Notification Details

Device IDK132505
510k NumberK132505
Device Name:ACCULIF TL AND PL CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant COALIGN INNOVATIONS, INC. 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327067118 K132505 000
07613327067101 K132505 000
37613327067096 K132505 000
37613327067089 K132505 000
07613327067071 K132505 000
07613327067064 K132505 000
07613327066753 K132505 000

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