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FDA 510(k)

MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

K-Number: K093425 · 2010-02-24

ApplicantMako Surgical Corp.
Decision Date2010-02-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA 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 2010-02-24 under 510(k) number K093425. 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 MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA?

MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Mako Surgical Corp.. The 510(k) number is K093425.

When did MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA receive FDA 510(k) clearance?

MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA received FDA 510(k) clearance on 2010-02-24, under 510(k) number K093425.

Who is the listed applicant for MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA?

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 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA?

The FDA product code for MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA is OLO.

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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: 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

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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