Paonan Armstrong Posterior Spinal Fixation System
K-Number: K161225 · 2017-08-11
ApplicantPaonan Biotech Co., Ltd.
Decision Date2017-08-11
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Paonan Armstrong Posterior Spinal Fixation System is a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-08-11 under approval number K161225. 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 Paonan Armstrong Posterior Spinal Fixation System?
Paonan Armstrong Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K161225.
When was Paonan Armstrong Posterior Spinal Fixation System approved by the FDA?
Paonan Armstrong Posterior Spinal Fixation System received FDA 510(k) clearance on 2017-08-11, under approval number K161225.
What company makes Paonan Armstrong Posterior Spinal Fixation System?
Paonan Armstrong Posterior Spinal Fixation System is manufactured by Paonan Biotech Co., Ltd..
What is the FDA product code for Paonan Armstrong Posterior Spinal Fixation System?
The FDA product code for Paonan Armstrong Posterior Spinal 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.