MARVEL Growing Rods
K-Number: K213196 · 2022-12-19
ApplicantGlobus Medical, Inc.
Decision Date2022-12-19
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MARVEL Growing Rods is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-12-19 under approval number K213196. 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 MARVEL Growing Rods?
MARVEL Growing Rods is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Globus Medical, Inc.. The 510(k) number is K213196.
When was MARVEL Growing Rods approved by the FDA?
MARVEL Growing Rods received FDA 510(k) clearance on 2022-12-19, under approval number K213196.
What company makes MARVEL Growing Rods?
MARVEL Growing Rods is manufactured by Globus Medical, Inc..
What is the FDA product code for MARVEL Growing Rods?
The FDA product code for MARVEL Growing Rods is PGM.
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K151665SUSTAIN Additional Implants
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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.