PISCES-SA Standalone ALIF Interbody System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Osseus Fusion Systems

The following data is part of a premarket notification filed by Osseus Fusion Systems with the FDA for Pisces-sa Standalone Alif Interbody System.

Pre-market Notification Details

Device IDK213935
510k NumberK213935
Device Name:PISCES-SA Standalone ALIF Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Osseus Fusion Systems 1931 Greenville Ave Suite 200 Dallas,  TX  75206
ContactJonathan Rosen
CorrespondentDaniel Johnson
Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake,  OH  44145
Product CodeOVD  
Subsequent Product CodeMAX
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-16
Decision Date2022-05-06

NIH GUDID Devices

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