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FDA 510(k)

ORTHOMESH

K-Number: K073115 · 2008-07-15

ApplicantSynthes (Usa)
Decision Date2008-07-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMESH is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K073115. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOMESH?

ORTHOMESH is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Synthes (Usa). The 510(k) number is K073115.

When did ORTHOMESH receive FDA 510(k) clearance?

ORTHOMESH received FDA 510(k) clearance on 2008-07-15, under 510(k) number K073115.

Who is the listed applicant for ORTHOMESH?

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

What is the FDA product code for ORTHOMESH?

The FDA product code for ORTHOMESH is HRS.

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Other records listing Synthes (Usa) as applicant

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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.

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