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FDA 510(k)

SODEM PERFORATOR DRIVE

K-Number: K993851 · 1999-12-27

ApplicantSodemsystems
Decision Date1999-12-27
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SODEM PERFORATOR DRIVE is the device name listed in this FDA 510(k) record. The listed applicant is Sodemsystems. It received FDA 510(k) clearance on 1999-12-27 under 510(k) number K993851. 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 SODEM PERFORATOR DRIVE?

SODEM PERFORATOR DRIVE is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Sodemsystems. The 510(k) number is K993851.

When did SODEM PERFORATOR DRIVE receive FDA 510(k) clearance?

SODEM PERFORATOR DRIVE received FDA 510(k) clearance on 1999-12-27, under 510(k) number K993851.

Who is the listed applicant for SODEM PERFORATOR DRIVE?

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 SODEM PERFORATOR DRIVE?

The FDA product code for SODEM PERFORATOR DRIVE 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)K994175MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

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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