FDA 510(k)

SYNTHES CONTOURED SYNMESH SPACER

K-Number: K041389 · 2004-10-01

Decision Date2004-10-01

Product CodeMQP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SYNTHES CONTOURED SYNMESH SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2004-10-01 under 510(k) number K041389. 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 SYNTHES CONTOURED SYNMESH SPACER?

SYNTHES CONTOURED SYNMESH SPACER is a medical device that received FDA 510(k) clearance on 2004-10-01. The listed applicant is Synthes Spine. The 510(k) number is K041389.

When did SYNTHES CONTOURED SYNMESH SPACER receive FDA 510(k) clearance?

SYNTHES CONTOURED SYNMESH SPACER received FDA 510(k) clearance on 2004-10-01, under 510(k) number K041389.

Who is the listed applicant for SYNTHES CONTOURED SYNMESH SPACER?

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

What is the FDA product code for SYNTHES CONTOURED SYNMESH SPACER?

The FDA product code for SYNTHES CONTOURED SYNMESH SPACER 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.