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FDA 510(k)

ADVANTAGE DRIVE SYSTEM

K-Number: K002523 · 2000-10-06

ApplicantLinvatec Corp.
Decision Date2000-10-06
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE DRIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2000-10-06 under 510(k) number K002523. 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 ADVANTAGE DRIVE SYSTEM?

ADVANTAGE DRIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-10-06. The listed applicant is Linvatec Corp.. The 510(k) number is K002523.

When did ADVANTAGE DRIVE SYSTEM receive FDA 510(k) clearance?

ADVANTAGE DRIVE SYSTEM received FDA 510(k) clearance on 2000-10-06, under 510(k) number K002523.

Who is the listed applicant for ADVANTAGE DRIVE SYSTEM?

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

What is the FDA product code for ADVANTAGE DRIVE SYSTEM?

The FDA product code for ADVANTAGE DRIVE SYSTEM is HBC.

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Other records listing Linvatec Corp. 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.

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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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