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FDA 510(k)

MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP

K-Number: K083644 · 2009-06-19

ApplicantMako Surgical Corp.
Decision Date2009-06-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP 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 2009-06-19 under 510(k) number K083644. 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 TACTILE GUIDANCE SYSTEM-HIP?

MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP is a medical device that received FDA 510(k) clearance on 2009-06-19. The listed applicant is Mako Surgical Corp.. The 510(k) number is K083644.

When did MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP receive FDA 510(k) clearance?

MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP received FDA 510(k) clearance on 2009-06-19, under 510(k) number K083644.

Who is the listed applicant for MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP?

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 TACTILE GUIDANCE SYSTEM-HIP?

The FDA product code for MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP 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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