Primus Spinal Fixation System
K-Number: K243916 · 2025-02-21
ApplicantSpinal Elements, Inc.
Decision Date2025-02-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Primus Spinal Fixation System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2025-02-21 under approval number K243916. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Primus Spinal Fixation System?
Primus Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K243916.
When was Primus Spinal Fixation System approved by the FDA?
Primus Spinal Fixation System received FDA 510(k) clearance on 2025-02-21, under approval number K243916.
What company makes Primus Spinal Fixation System?
Primus Spinal Fixation System is manufactured by Spinal Elements, Inc..
What is the FDA product code for Primus Spinal Fixation System?
The FDA product code for Primus Spinal Fixation System is NKB.
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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.