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FDA 510(k)

NUGEN FX SCREW

K-Number: K023022 · 2002-10-04

ApplicantBionx Implants, Inc.
Decision Date2002-10-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUGEN FX SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 2002-10-04 under 510(k) number K023022. 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 NUGEN FX SCREW?

NUGEN FX SCREW is a medical device that received FDA 510(k) clearance on 2002-10-04. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K023022.

When did NUGEN FX SCREW receive FDA 510(k) clearance?

NUGEN FX SCREW received FDA 510(k) clearance on 2002-10-04, under 510(k) number K023022.

Who is the listed applicant for NUGEN FX SCREW?

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

What is the FDA product code for NUGEN FX SCREW?

The FDA product code for NUGEN FX SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Bionx Implants, 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.

K011569BIOSORBFX O/M 2.0/2/4 SYSTEMK013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214K013057BIOCUFF,C, MODELS 236018, 236028, 236036K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116K010983PLLA PINK010554MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

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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

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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