K2M Growing Spine System
K-Number: K161028 · 2016-07-22
ApplicantK2m, Inc.
Decision Date2016-07-22
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
K2M Growing Spine System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2016-07-22 under approval number K161028. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the K2M Growing Spine System?
K2M Growing Spine System is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by K2m, Inc.. The 510(k) number is K161028.
When was K2M Growing Spine System approved by the FDA?
K2M Growing Spine System received FDA 510(k) clearance on 2016-07-22, under approval number K161028.
What company makes K2M Growing Spine System?
K2M Growing Spine System is manufactured by K2m, Inc..
What is the FDA product code for K2M Growing Spine System?
The FDA product code for K2M Growing Spine System is PGM.
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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.