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FDA 510(k)

G-FORCE TENODESIS SCREW

K-Number: K083150 · 2009-01-15

ApplicantWrightmedicaltechnologyinc
Decision Date2009-01-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G-FORCE TENODESIS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K083150. 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 G-FORCE TENODESIS SCREW?

G-FORCE TENODESIS SCREW is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K083150.

When did G-FORCE TENODESIS SCREW receive FDA 510(k) clearance?

G-FORCE TENODESIS SCREW received FDA 510(k) clearance on 2009-01-15, under 510(k) number K083150.

Who is the listed applicant for G-FORCE TENODESIS SCREW?

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

What is the FDA product code for G-FORCE TENODESIS SCREW?

The FDA product code for G-FORCE TENODESIS SCREW is MBI.

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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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