• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K191489, Genesys Spine 3DP Cervical Interbody System, by Genesys Spine

FDA 510(k) K191489, Genesys Spine 3DP Cervical Interbody System, by Genesys Spine

$392.19 USD
$392.19 USD
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510(K) Number: K191489
Device Name: Genesys Spine 3DP Cervical Interbody System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 06/04/2019
Decision Date: 01/08/2020
Regulation Medical Specialty: Orthopedic

Total pages: 850
Fully redacted pages: 714
Content pages: 136
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