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FDA 510(k)

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

K-Number: K043339 · 2005-04-18

ApplicantXtremi-T, LLC
Decision Date2005-04-18
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG 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 2005-04-18 under 510(k) number K043339. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG?

REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG is a medical device that received FDA 510(k) clearance on 2005-04-18. The listed applicant is Xtremi-T, LLC. The 510(k) number is K043339.

When did REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG receive FDA 510(k) clearance?

REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG received FDA 510(k) clearance on 2005-04-18, under 510(k) number K043339.

Who is the listed applicant for REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG?

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

The FDA product code for REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K050388REFIX INTERNAL FRACTURE FIXATION SCREWS

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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