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FDA 510(k)

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

K-Number: K994175 · 1999-12-21

ApplicantSodemsystems
Decision Date1999-12-21
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Sodemsystems. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K994175. 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 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE?

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Sodemsystems. The 510(k) number is K994175.

When did MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE receive FDA 510(k) clearance?

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE received FDA 510(k) clearance on 1999-12-21, under 510(k) number K994175.

Who is the listed applicant for MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE?

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

What is the FDA product code for MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE?

The FDA product code for MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE is HBB.

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Other records listing Sodemsystems 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.

K023070SODEM HIGH SPEED SYSTEM (PNEUMATIC)K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)K993851SODEM PERFORATOR DRIVE

View all 8 devices →

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)K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions

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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