Black Diamond POCT Spinal System
K-Number: K222107 · 2022-11-03
ApplicantOsseus Fusion Systems
Decision Date2022-11-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Black Diamond POCT Spinal System is a medical device manufactured by Osseus Fusion Systems. It received FDA 510(k) clearance on 2022-11-03 under approval number K222107. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Black Diamond POCT Spinal System?
Black Diamond POCT Spinal System is a medical device that received FDA 510(k) clearance on 2022-11-03. It is manufactured by Osseus Fusion Systems. The 510(k) number is K222107.
When was Black Diamond POCT Spinal System approved by the FDA?
Black Diamond POCT Spinal System received FDA 510(k) clearance on 2022-11-03, under approval number K222107.
What company makes Black Diamond POCT Spinal System?
Black Diamond POCT Spinal System is manufactured by Osseus Fusion Systems.
What is the FDA product code for Black Diamond POCT Spinal System?
The FDA product code for Black Diamond POCT Spinal System is NKG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.