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FDA 510(k) Applications Submitted by Osseus Fusion Systems
FDA 510(k) Number
Submission Date
Device Name
Applicant
K222107
07/18/2022
Black DiamondÖ POCT Spinal System
Osseus Fusion Systems
K223413
11/09/2022
PiscesÖ-SA STANDALONE ALIF Interbody System
Osseus Fusion Systems
K213935
12/16/2021
PISCES-SA Standalone ALIF Interbody System
Osseus Fusion Systems
K192121
08/06/2019
Black Diamond Pedicle Screw System
Osseus Fusion Systems
K192495
09/11/2019
Black Diamond Navigation Instruments
Osseus Fusion Systems
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