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FDA 510(k)

MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM

K-Number: K082172 · 2008-11-28

ApplicantMako Surgical Corporation
Decision Date2008-11-28
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corporation. It received FDA 510(k) clearance on 2008-11-28 under 510(k) number K082172. 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 MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM?

MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-28. The listed applicant is Mako Surgical Corporation. The 510(k) number is K082172.

When did MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2008-11-28, under 510(k) number K082172.

Who is the listed applicant for MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM?

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

What is the FDA product code for MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM?

The FDA product code for MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM is HSX.

Related Clinical Trials

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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Other records listing Mako Surgical Corporation 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.

K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMK121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMK112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMK090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM

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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