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FDA 510(k)

ORTHOSENSOR KNEE BALANCER

K-Number: K130380 · 2013-06-13

ApplicantOrthosensor, Inc.
Decision Date2013-06-13
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOSENSOR KNEE BALANCER is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2013-06-13 under 510(k) number K130380. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSENSOR KNEE BALANCER?

ORTHOSENSOR KNEE BALANCER is a medical device that received FDA 510(k) clearance on 2013-06-13. The listed applicant is Orthosensor, Inc.. The 510(k) number is K130380.

When did ORTHOSENSOR KNEE BALANCER receive FDA 510(k) clearance?

ORTHOSENSOR KNEE BALANCER received FDA 510(k) clearance on 2013-06-13, under 510(k) number K130380.

Who is the listed applicant for ORTHOSENSOR KNEE BALANCER?

The FDA 510(k) record lists Orthosensor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOSENSOR KNEE BALANCER?

The FDA product code for ORTHOSENSOR KNEE BALANCER is ONN.

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Other records listing Orthosensor, Inc. 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.

K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderK200665VERASENSE for Stryker TriathlonK193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeftK180459VERASENSE for Zimmer Biomet PersonaK150372VERASENSE Knee SystemK131767ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

View all 8 devices →

Related Devices (Code: ONN)

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.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, Inc.K220830TrueBalance™ Surgical SystemThese Three Medical, LLC

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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