Polaris Spinal Growth System
K-Number: K180227 · 2018-03-15
ApplicantZimmer Biomet Spine, Inc.
Decision Date2018-03-15
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Polaris Spinal Growth System is a medical device manufactured by Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2018-03-15 under approval number K180227. 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 Polaris Spinal Growth System?
Polaris Spinal Growth System is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Zimmer Biomet Spine, Inc.. The 510(k) number is K180227.
When was Polaris Spinal Growth System approved by the FDA?
Polaris Spinal Growth System received FDA 510(k) clearance on 2018-03-15, under approval number K180227.
What company makes Polaris Spinal Growth System?
Polaris Spinal Growth System is manufactured by Zimmer Biomet Spine, Inc..
What is the FDA product code for Polaris Spinal Growth System?
The FDA product code for Polaris Spinal Growth 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.