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FDA 510(k)

VERTIFLEX DIRECT DECOMPRESSION SYSTEM

K-Number: K122662 · 2012-11-13

ApplicantVertiflex, Inc.
Decision Date2012-11-13
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTIFLEX DIRECT DECOMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vertiflex, Inc.. It received FDA 510(k) clearance on 2012-11-13 under 510(k) number K122662. 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 VERTIFLEX DIRECT DECOMPRESSION SYSTEM?

VERTIFLEX DIRECT DECOMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-13. The listed applicant is Vertiflex, Inc.. The 510(k) number is K122662.

When did VERTIFLEX DIRECT DECOMPRESSION SYSTEM receive FDA 510(k) clearance?

VERTIFLEX DIRECT DECOMPRESSION SYSTEM received FDA 510(k) clearance on 2012-11-13, under 510(k) number K122662.

Who is the listed applicant for VERTIFLEX DIRECT DECOMPRESSION SYSTEM?

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

What is the FDA product code for VERTIFLEX DIRECT DECOMPRESSION SYSTEM?

The FDA product code for VERTIFLEX DIRECT DECOMPRESSION SYSTEM is HRX.

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Other records listing Vertiflex, 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.

K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATEK082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMK073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEMK073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEM

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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