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FDA 510(k)

MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II

K-Number: K080368 · 2008-06-20

ApplicantMako Surgical Corp.
Decision Date2008-06-20
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II 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 2008-06-20 under 510(k) number K080368. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II?

MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Mako Surgical Corp.. The 510(k) number is K080368.

When did MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II receive FDA 510(k) clearance?

MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080368.

Who is the listed applicant for MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II?

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 MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II?

The FDA product code for MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II is HSX.

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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: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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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