Admiral ACP System

Appliance, Fixation, Spinal Intervertebral Body

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Admiral Acp System.

Pre-market Notification Details

Device IDK212139
510k NumberK212139
Device Name:Admiral ACP System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactCindy Fong
CorrespondentCindy Fong
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-08
Decision Date2021-09-01

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