FDA.report

510(k) K192132

Device
SeaSpine Beachside System
Applicant
SeaSpine Orthopedics Corporation
510(k) number
K192132
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-03
Date received
2019-08-07
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Aly Alvarez
Address
5770 Armada Dr. Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

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FDA Review

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