PERLA® TL posterior osteosynthesis system
K-Number: K193396 · 2020-02-05
ApplicantSpineart
Decision Date2020-02-05
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 2020-02-05 under approval number K193396. 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 2020-02-05. It is manufactured by Spineart. The 510(k) number is K193396.
When was PERLA® TL posterior osteosynthesis system approved by the FDA?
PERLA® TL posterior osteosynthesis system received FDA 510(k) clearance on 2020-02-05, under approval number K193396.
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.