Perla Posterior Cervico-Thoracic Fixation system
K-Number: K153386 · 2016-01-25
ApplicantSpineart
Decision Date2016-01-25
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Perla Posterior Cervico-Thoracic Fixation system is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2016-01-25 under approval number K153386. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Perla Posterior Cervico-Thoracic Fixation system?
Perla Posterior Cervico-Thoracic Fixation system is a medical device that received FDA 510(k) clearance on 2016-01-25. It is manufactured by Spineart. The 510(k) number is K153386.
When was Perla Posterior Cervico-Thoracic Fixation system approved by the FDA?
Perla Posterior Cervico-Thoracic Fixation system received FDA 510(k) clearance on 2016-01-25, under approval number K153386.
What company makes Perla Posterior Cervico-Thoracic Fixation system?
Perla Posterior Cervico-Thoracic Fixation system is manufactured by Spineart.
What is the FDA product code for Perla Posterior Cervico-Thoracic Fixation system?
The FDA product code for Perla Posterior Cervico-Thoracic Fixation system is NKG.
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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.