PERLA® TL Posterior Osteosynthesis System
K-Number: K213470 · 2022-01-21
ApplicantSpineart
Decision Date2022-01-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PERLA® TL Posterior Osteosynthesis System is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2022-01-21 under approval number K213470. 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 Osteosynthesis System?
PERLA® TL Posterior Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2022-01-21. It is manufactured by Spineart. The 510(k) number is K213470.
When was PERLA® TL Posterior Osteosynthesis System approved by the FDA?
PERLA® TL Posterior Osteosynthesis System received FDA 510(k) clearance on 2022-01-21, under approval number K213470.
What company makes PERLA® TL Posterior Osteosynthesis System?
PERLA® TL Posterior Osteosynthesis System is manufactured by Spineart.
What is the FDA product code for PERLA® TL Posterior Osteosynthesis System?
The FDA product code for PERLA® TL Posterior Osteosynthesis 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.