ATLAS SPINE SPACER

Intervertebral Fusion Device With Bone Graft, Cervical

ATLAS SPINE INC.

The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Atlas Spine Spacer.

Pre-market Notification Details

Device IDK081880
510k NumberK081880
Device Name:ATLAS SPINE SPACER
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter,  FL  33458
ContactJeannette G Dailey
CorrespondentJeannette G Dailey
ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter,  FL  33458
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-02
Decision Date2008-10-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M681SCC0020140 K081880 000
M681SCC0010130 K081880 000
M681SCC0010120 K081880 000
M681SCC0010111 K081880 000
M681SCC0010100 K081880 000
M681SCC0010090 K081880 000
M681SCC0010080 K081880 000
M681SCC0010070 K081880 000
M681SCC0010060 K081880 000
M681SCC0010140 K081880 000
M681SCC0020050 K081880 000
M681SCC0020130 K081880 000
M681SCC0020120 K081880 000
M681SCC0020110 K081880 000
M681SCC0020100 K081880 000
M681SCC0020090 K081880 000
M681SCC0020080 K081880 000
M681SCC0020070 K081880 000
M681SCC0020060 K081880 000
M681SCC0010050 K081880 000

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