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FDA 510(k)

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM

K-Number: K112507 · 2012-03-01

ApplicantMako Surgical Corporation
Decision Date2012-03-01
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD 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 2012-03-01 under 510(k) number K112507. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM?

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-01. The listed applicant is Mako Surgical Corporation. The 510(k) number is K112507.

When did RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM receive FDA 510(k) clearance?

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM received FDA 510(k) clearance on 2012-03-01, under 510(k) number K112507.

Who is the listed applicant for RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD 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 PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM?

The FDA product code for RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM is OLO.

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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 SYSTEMK090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMK082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM

Related Devices (Code: OLO)

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.

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLCK261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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