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FDA 510(k)

GO INTRAMEDULLARY NAIL LOCKING SCREW

K-Number: K954511 · 1995-12-19

ApplicantGenesis Orthopedics, Inc.
Decision Date1995-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GO INTRAMEDULLARY NAIL LOCKING SCREW 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 1995-12-19 under 510(k) number K954511. 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 for Some Indications.

Frequently Asked Questions

What is the GO INTRAMEDULLARY NAIL LOCKING SCREW?

GO INTRAMEDULLARY NAIL LOCKING SCREW is a medical device that received FDA 510(k) clearance on 1995-12-19. The listed applicant is Genesis Orthopedics, Inc.. The 510(k) number is K954511.

When did GO INTRAMEDULLARY NAIL LOCKING SCREW receive FDA 510(k) clearance?

GO INTRAMEDULLARY NAIL LOCKING SCREW received FDA 510(k) clearance on 1995-12-19, under 510(k) number K954511.

Who is the listed applicant for GO INTRAMEDULLARY NAIL LOCKING SCREW?

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 INTRAMEDULLARY NAIL LOCKING SCREW?

The FDA product code for GO INTRAMEDULLARY NAIL LOCKING SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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.

K954543GO UNIVERSALK-WIRE FLUTED DRILL

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

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