PERLA TL Posterior Osteosynthesis System
K-Number: K203222 · 2020-12-17
ApplicantSpineart
Decision Date2020-12-17
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 2020-12-17 under approval number K203222. 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 2020-12-17. It is manufactured by Spineart. The 510(k) number is K203222.
When was PERLA TL Posterior Osteosynthesis System approved by the FDA?
PERLA TL Posterior Osteosynthesis System received FDA 510(k) clearance on 2020-12-17, under approval number K203222.
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.