PERLA® TL Posterior Thoraco-lumbar Fixation System
K-Number: K231069 · 2023-10-25
ApplicantSpineart SA
Decision Date2023-10-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PERLA® TL Posterior Thoraco-lumbar Fixation System is a medical device manufactured by Spineart SA. It received FDA 510(k) clearance on 2023-10-25 under approval number K231069. 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 PERLA® TL Posterior Thoraco-lumbar Fixation System?
PERLA® TL Posterior Thoraco-lumbar Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Spineart SA. The 510(k) number is K231069.
When was PERLA® TL Posterior Thoraco-lumbar Fixation System approved by the FDA?
PERLA® TL Posterior Thoraco-lumbar Fixation System received FDA 510(k) clearance on 2023-10-25, under approval number K231069.
What company makes PERLA® TL Posterior Thoraco-lumbar Fixation System?
PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured by Spineart SA.
What is the FDA product code for PERLA® TL Posterior Thoraco-lumbar Fixation System?
The FDA product code for PERLA® TL Posterior Thoraco-lumbar Fixation System is NKB.
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Official Source
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