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FDA 510(k)

VERTOS MEDICAL MILD DEVICE KIT

K-Number: K093062 · 2010-02-04

ApplicantX-Sten Corp.
Decision Date2010-02-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTOS MEDICAL MILD DEVICE KIT is the device name listed in this FDA 510(k) record. The listed applicant is X-Sten Corp.. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K093062. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTOS MEDICAL MILD DEVICE KIT?

VERTOS MEDICAL MILD DEVICE KIT is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is X-Sten Corp.. The 510(k) number is K093062.

When did VERTOS MEDICAL MILD DEVICE KIT receive FDA 510(k) clearance?

VERTOS MEDICAL MILD DEVICE KIT received FDA 510(k) clearance on 2010-02-04, under 510(k) number K093062.

Who is the listed applicant for VERTOS MEDICAL MILD DEVICE KIT?

The FDA 510(k) record lists X-Sten Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTOS MEDICAL MILD DEVICE KIT?

The FDA product code for VERTOS MEDICAL MILD DEVICE KIT is HRX.

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.

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Other records listing X-Sten Corp. 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.

K062038X-STEN MILD TOOL KIT, MODEL MTK-0001

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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