PERLA® TL Posterior Thoraco-lumbar Fixation System
K-Number: K253966 · 2026-05-01
ApplicantSpineart SA
Decision Date2026-05-01
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 2026-05-01 under approval number K253966. 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 2026-05-01. It is manufactured by Spineart SA. The 510(k) number is K253966.
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 2026-05-01, under approval number K253966.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.