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FDA 510(k)

VERTIFLEX SPINOUS PROCESS FIXATION PLATE

K-Number: K122509 · 2012-12-17

ApplicantVertiflex, Inc.
Decision Date2012-12-17
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTIFLEX SPINOUS PROCESS FIXATION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Vertiflex, Inc.. It received FDA 510(k) clearance on 2012-12-17 under 510(k) number K122509. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTIFLEX SPINOUS PROCESS FIXATION PLATE?

VERTIFLEX SPINOUS PROCESS FIXATION PLATE is a medical device that received FDA 510(k) clearance on 2012-12-17. The listed applicant is Vertiflex, Inc.. The 510(k) number is K122509.

When did VERTIFLEX SPINOUS PROCESS FIXATION PLATE receive FDA 510(k) clearance?

VERTIFLEX SPINOUS PROCESS FIXATION PLATE received FDA 510(k) clearance on 2012-12-17, under 510(k) number K122509.

Who is the listed applicant for VERTIFLEX SPINOUS PROCESS FIXATION PLATE?

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 SPINOUS PROCESS FIXATION PLATE?

The FDA product code for VERTIFLEX SPINOUS PROCESS FIXATION PLATE is KWP.

Related Clinical Trials

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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.

K122662VERTIFLEX DIRECT DECOMPRESSION SYSTEMK082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMK073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEMK073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEM

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

Official Source

View on FDA Database →

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

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