FDA 510(k)

SYNMESH System

K-Number: K183054 · 2019-05-23

Decision Date2019-05-23

Product CodeMQP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SYNMESH System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Synthes Spine. It received FDA 510(k) clearance on 2019-05-23 under 510(k) 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. The listed applicant is Depuy Synthes Spine. The 510(k) number is K183054.

When did SYNMESH System receive FDA 510(k) clearance?

SYNMESH System received FDA 510(k) clearance on 2019-05-23, under 510(k) number K183054.

Who is the listed applicant for SYNMESH System?

The FDA 510(k) record lists Depuy Synthes Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNMESH System?

The FDA product code for SYNMESH System is MQP.

Other records listing Depuy Synthes Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181231DePuy Synthes T-PAL Spacer System

Related Devices (Code: MQP)

K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group K261031POSEIDON STSignus Medinzintechnik GmbH K253158VyBrate™ VBR SystemVy Spine, LLC K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG K233359DOMINION Expandable Corpectomy SystemAstura Medical

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.