SPIRA® Posterior Lumbar Spacers
K-Number: K230942 · 2023-07-11
ApplicantCamber Spine Technologies
Decision Date2023-07-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SPIRA® Posterior Lumbar Spacers is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2023-07-11 under approval number K230942. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SPIRA® Posterior Lumbar Spacers?
SPIRA® Posterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2023-07-11. It is manufactured by Camber Spine Technologies. The 510(k) number is K230942.
When was SPIRA® Posterior Lumbar Spacers approved by the FDA?
SPIRA® Posterior Lumbar Spacers received FDA 510(k) clearance on 2023-07-11, under approval number K230942.
What company makes SPIRA® Posterior Lumbar Spacers?
SPIRA® Posterior Lumbar Spacers is manufactured by Camber Spine Technologies.
What is the FDA product code for SPIRA® Posterior Lumbar Spacers?
The FDA product code for SPIRA® Posterior Lumbar Spacers is MAX.
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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.