SYNMESH System
K-Number: K183054 · 2019-05-23
ApplicantDepuy Synthes Spine
Decision Date2019-05-23
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SYNMESH System is a medical device manufactured by Depuy Synthes Spine. It received FDA 510(k) clearance on 2019-05-23 under approval number K183054. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SYNMESH System?
SYNMESH System is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Depuy Synthes Spine. The 510(k) number is K183054.
When was SYNMESH System approved by the FDA?
SYNMESH System received FDA 510(k) clearance on 2019-05-23, under approval number K183054.
What company makes SYNMESH System?
SYNMESH System is manufactured by Depuy Synthes Spine.
What is the FDA product code for SYNMESH System?
The FDA product code for SYNMESH System is MQP.
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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.