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FDA 510(k)

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)

K-Number: K012457 · 2001-10-22

ApplicantSodemsystems
Decision Date2001-10-22
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) is the device name listed in this FDA 510(k) record. The listed applicant is Sodemsystems. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012457. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)?

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Sodemsystems. The 510(k) number is K012457.

When did SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) receive FDA 510(k) clearance?

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012457.

Who is the listed applicant for SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)?

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 HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)?

The FDA product code for SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) is HBC.

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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)K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)K993851SODEM PERFORATOR DRIVEK994175MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

View all 8 devices →

Related Devices (Code: HBC)

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.

K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

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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