FDA 510(k)

OMNITECH LARGE, TRIMED COMPRESSION SCREW

K-Number: K093676 · 2010-03-17

Decision Date2010-03-17

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OMNITECH LARGE, TRIMED COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2010-03-17 under 510(k) number K093676. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNITECH LARGE, TRIMED COMPRESSION SCREW?

OMNITECH LARGE, TRIMED COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2010-03-17. The listed applicant is TriMed, Inc.. The 510(k) number is K093676.

When did OMNITECH LARGE, TRIMED COMPRESSION SCREW receive FDA 510(k) clearance?

OMNITECH LARGE, TRIMED COMPRESSION SCREW received FDA 510(k) clearance on 2010-03-17, under 510(k) number K093676.

Who is the listed applicant for OMNITECH LARGE, TRIMED COMPRESSION SCREW?

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

What is the FDA product code for OMNITECH LARGE, TRIMED COMPRESSION SCREW?

The FDA product code for OMNITECH LARGE, TRIMED COMPRESSION SCREW is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.