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FDA 510(k)

REFIX INTERNAL FRACTURE FIXATION SCREWS

K-Number: K050388 · 2005-09-07

ApplicantXtremi-T, LLC
Decision Date2005-09-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REFIX INTERNAL FRACTURE FIXATION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Xtremi-T, LLC. It received FDA 510(k) clearance on 2005-09-07 under 510(k) number K050388. 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 REFIX INTERNAL FRACTURE FIXATION SCREWS?

REFIX INTERNAL FRACTURE FIXATION SCREWS is a medical device that received FDA 510(k) clearance on 2005-09-07. The listed applicant is Xtremi-T, LLC. The 510(k) number is K050388.

When did REFIX INTERNAL FRACTURE FIXATION SCREWS receive FDA 510(k) clearance?

REFIX INTERNAL FRACTURE FIXATION SCREWS received FDA 510(k) clearance on 2005-09-07, under 510(k) number K050388.

Who is the listed applicant for REFIX INTERNAL FRACTURE FIXATION SCREWS?

The FDA 510(k) record lists Xtremi-T, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFIX INTERNAL FRACTURE FIXATION SCREWS?

The FDA product code for REFIX INTERNAL FRACTURE FIXATION SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Xtremi-T, LLC 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.

K043339REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG

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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