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FDA 510(k)

GO UNIVERSALK-WIRE FLUTED DRILL

K-Number: K954543 · 1995-12-08

ApplicantGenesis Orthopedics, Inc.
Decision Date1995-12-08
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GO UNIVERSALK-WIRE FLUTED DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Orthopedics, Inc.. It received FDA 510(k) clearance on 1995-12-08 under 510(k) number K954543. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GO UNIVERSALK-WIRE FLUTED DRILL?

GO UNIVERSALK-WIRE FLUTED DRILL is a medical device that received FDA 510(k) clearance on 1995-12-08. The listed applicant is Genesis Orthopedics, Inc.. The 510(k) number is K954543.

When did GO UNIVERSALK-WIRE FLUTED DRILL receive FDA 510(k) clearance?

GO UNIVERSALK-WIRE FLUTED DRILL received FDA 510(k) clearance on 1995-12-08, under 510(k) number K954543.

Who is the listed applicant for GO UNIVERSALK-WIRE FLUTED DRILL?

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

What is the FDA product code for GO UNIVERSALK-WIRE FLUTED DRILL?

The FDA product code for GO UNIVERSALK-WIRE FLUTED DRILL is HTY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Genesis Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954511GO INTRAMEDULLARY NAIL LOCKING SCREW

Related Devices (Code: HTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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