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FDA 510(k)

ORTHOREX INTRA-OPERATIVE LOAD SENSOR

K-Number: K090474 · 2009-10-19

ApplicantOrthosensor, Inc.
Decision Date2009-10-19
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOREX INTRA-OPERATIVE LOAD SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2009-10-19 under 510(k) number K090474. 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 ORTHOREX INTRA-OPERATIVE LOAD SENSOR?

ORTHOREX INTRA-OPERATIVE LOAD SENSOR is a medical device that received FDA 510(k) clearance on 2009-10-19. The listed applicant is Orthosensor, Inc.. The 510(k) number is K090474.

When did ORTHOREX INTRA-OPERATIVE LOAD SENSOR receive FDA 510(k) clearance?

ORTHOREX INTRA-OPERATIVE LOAD SENSOR received FDA 510(k) clearance on 2009-10-19, under 510(k) number K090474.

Who is the listed applicant for ORTHOREX INTRA-OPERATIVE LOAD SENSOR?

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 ORTHOREX INTRA-OPERATIVE LOAD SENSOR?

The FDA product code for ORTHOREX INTRA-OPERATIVE LOAD SENSOR is ONN.

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Other records listing Orthosensor, Inc. as applicant

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Related Devices (Code: ONN)

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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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