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FDA 510(k)

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM

K-Number: K080029 · 2008-05-16

ApplicantMako Surgical Corp.
Decision Date2008-05-16
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM 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 2008-05-16 under 510(k) number K080029. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM?

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-16. The listed applicant is Mako Surgical Corp.. The 510(k) number is K080029.

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

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM received FDA 510(k) clearance on 2008-05-16, under 510(k) number K080029.

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

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. PATELLOFEMORAL KNEE IMPLANT SYSTEM?

The FDA product code for MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM is KRR.

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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 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: KRR)

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.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Arthrex iBalance BiCompartmental Arthroplasty 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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