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FDA 510(k)

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED

K-Number: K032447 · 2004-04-16

ApplicantLinvatec Biomaterials, Ltd.
Decision Date2004-04-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Ltd.. It received FDA 510(k) clearance on 2004-04-16 under 510(k) number K032447. 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 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED?

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED is a medical device that received FDA 510(k) clearance on 2004-04-16. The listed applicant is Linvatec Biomaterials, Ltd.. The 510(k) number is K032447.

When did CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED receive FDA 510(k) clearance?

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED received FDA 510(k) clearance on 2004-04-16, under 510(k) number K032447.

Who is the listed applicant for CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED?

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

What is the FDA product code for CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED?

The FDA product code for CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Biomaterials, Ltd. 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.

K042966DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218HK042517BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWSK042295SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020K0319812.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

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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