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FDA 510(k)

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700

K-Number: K090112 · 2009-03-26

ApplicantMedtronic Powered Surgical Solutions
Decision Date2009-03-26
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2009-03-26 under 510(k) number K090112. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700?

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 is a medical device that received FDA 510(k) clearance on 2009-03-26. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K090112.

When did MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 receive FDA 510(k) clearance?

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 received FDA 510(k) clearance on 2009-03-26, under 510(k) number K090112.

Who is the listed applicant for MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700?

The FDA 510(k) record lists Medtronic Powered Surgical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700?

The FDA product code for MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 is HBB.

Related Clinical Trials

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Other records listing Medtronic Powered Surgical Solutions 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.

K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mmK183644Stealth-Midas MR8 SystemK183515MR8 Drill System, Midas Rex MR8 ClearView ToolsK170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsK163565MR8 Drill SystemK163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

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Related Devices (Code: HBB)

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.

K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AGK172907ELAN 4 Air Motor SystemAesculap, Inc.K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical SolutionsK101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor DanekK093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)K061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, 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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