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FDA 510(k)

TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD

K-Number: K081348 · 2008-10-17

ApplicantTriMed, Inc.
Decision Date2008-10-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K081348. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD?

TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is TriMed, Inc.. The 510(k) number is K081348.

When did TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD receive FDA 510(k) clearance?

TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD received FDA 510(k) clearance on 2008-10-17, under 510(k) number K081348.

Who is the listed applicant for TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD?

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 TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD?

The FDA product code for TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD is MBI.

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Other records listing TriMed, Inc. 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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