FDA.reportPublic FDA data

510(k) K220296

Device
Manta Ray TDF Spacer
Applicant
SeaSpine Orthopedics Corporation
510(k) number
K220296
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-03
Date received
2022-02-02
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kavita Chandrashekar
Address
5770 Armada Dr. Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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