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FDA 510(k)

MODIFICATION TO: VOYAGER LINUX

K-Number: K050973 · 2005-05-17

ApplicantMako Surgical Corp.
Decision Date2005-05-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VOYAGER LINUX is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2005-05-17 under 510(k) number K050973. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: VOYAGER LINUX?

MODIFICATION TO: VOYAGER LINUX is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Mako Surgical Corp.. The 510(k) number is K050973.

When did MODIFICATION TO: VOYAGER LINUX receive FDA 510(k) clearance?

MODIFICATION TO: VOYAGER LINUX received FDA 510(k) clearance on 2005-05-17, under 510(k) number K050973.

Who is the listed applicant for MODIFICATION TO: VOYAGER LINUX?

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

What is the FDA product code for MODIFICATION TO: VOYAGER LINUX?

The FDA product code for MODIFICATION TO: VOYAGER LINUX is HAW.

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Other records listing Mako Surgical 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.

K260222Mako Total Knee ApplicationK250608Mako Total Knee Application (3.0); Hybrid Tip PointerK243751Mako Total Hip Application 5.0K242373Mako Shoulder Application (1.0)K241011Mako Total Knee ApplicationK220930Restoris Multi-Compartmental Knee System

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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