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FDA 510(k)

MRII CRAINIAL DRILL

K-Number: K122456 · 2013-03-22

ApplicantMri Interventions, Inc.
Decision Date2013-03-22
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MRII CRAINIAL DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2013-03-22 under 510(k) number K122456. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRII CRAINIAL DRILL?

MRII CRAINIAL DRILL is a medical device that received FDA 510(k) clearance on 2013-03-22. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K122456.

When did MRII CRAINIAL DRILL receive FDA 510(k) clearance?

MRII CRAINIAL DRILL received FDA 510(k) clearance on 2013-03-22, under 510(k) number K122456.

Who is the listed applicant for MRII CRAINIAL DRILL?

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

What is the FDA product code for MRII CRAINIAL DRILL?

The FDA product code for MRII CRAINIAL DRILL is HBG.

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Other records listing Mri Interventions, Inc. as applicant

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Related Devices (Code: HBG)

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.

K252696LEGACYPhasor Health, LLCK153587Taps for Resorbable ScrewsSynthes (USA) Products, LLCK162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.K022712HAND DRILL, MODEL 11-9901-7Medical Design, LLCK022370FRAMELOCK; FRAMELOCK ACCESSORIESMedtronic Xomed, 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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