FDA.reportPublic FDA data

510(k) K223413

Device
Pisces?-SA STANDALONE ALIF Interbody System
Applicant
Osseus Fusion Systems
510(k) number
K223413
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-10
Date received
2022-11-09
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jonathan Rosen
Address
1931 Greenville Ave. Suite 200 Dallas TX US 75206 75206

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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