Reform® POCT System
K-Number: K162300 · 2016-11-22
ApplicantPrecision Spine, Inc.
Decision Date2016-11-22
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Reform® POCT System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval number K162300. 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 Reform® POCT System?
Reform® POCT System is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Precision Spine, Inc.. The 510(k) number is K162300.
When was Reform® POCT System approved by the FDA?
Reform® POCT System received FDA 510(k) clearance on 2016-11-22, under approval number K162300.
What company makes Reform® POCT System?
Reform® POCT System is manufactured by Precision Spine, Inc..
What is the FDA product code for Reform® POCT System?
The FDA product code for Reform® POCT System is NKG.
Other Devices by Precision Spine, Inc.
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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.