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FDA 510(k)

RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

K-Number: K133039 · 2013-12-10

ApplicantMako Surgical Corporation
Decision Date2013-12-10
Product CodeNPJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESTORIS MULTICOMPARTMENTAL KNEE 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 2013-12-10 under 510(k) number K133039. The device is classified under product code NPJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM?

RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-10. The listed applicant is Mako Surgical Corporation. The 510(k) number is K133039.

When did RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM receive FDA 510(k) clearance?

RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 2013-12-10, under 510(k) number K133039.

Who is the listed applicant for RESTORIS MULTICOMPARTMENTAL KNEE 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 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM is NPJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMK112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMK090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMK082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM

Related Devices (Code: NPJ)

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.

K093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.K093056SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSmith & Nephew, Inc.K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical CorporationK070849DEPUY GCK FEMORAL AND TIBIAL COMPONENTSDePuy Orthopaedics, Inc.K061648DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)DePuy Orthopaedics, Inc.K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSSmith & Nephew, 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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