SEASPINE SPACER SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Seaspine Spacer System.

Pre-market Notification Details

Device IDK102026
510k NumberK102026
Device Name:SEASPINE SPACER SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SEASPINE, INC. 2301 LA MIRADA DR Vista,  CA  92081
ContactDan Miller
CorrespondentDan Miller
SEASPINE, INC. 2301 LA MIRADA DR Vista,  CA  92081
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-19
Decision Date2011-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10889981034528 K102026 000

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