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FDA 510(k)

KNEEALIGN SYSTEM WITH REFERENCE SENSOR

K-Number: K093998 · 2010-03-22

ApplicantOrthalign, Inc.
Decision Date2010-03-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KNEEALIGN SYSTEM WITH REFERENCE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2010-03-22 under 510(k) number K093998. 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 KNEEALIGN SYSTEM WITH REFERENCE SENSOR?

KNEEALIGN SYSTEM WITH REFERENCE SENSOR is a medical device that received FDA 510(k) clearance on 2010-03-22. The listed applicant is Orthalign, Inc.. The 510(k) number is K093998.

When did KNEEALIGN SYSTEM WITH REFERENCE SENSOR receive FDA 510(k) clearance?

KNEEALIGN SYSTEM WITH REFERENCE SENSOR received FDA 510(k) clearance on 2010-03-22, under 510(k) number K093998.

Who is the listed applicant for KNEEALIGN SYSTEM WITH REFERENCE SENSOR?

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

What is the FDA product code for KNEEALIGN SYSTEM WITH REFERENCE SENSOR?

The FDA product code for KNEEALIGN SYSTEM WITH REFERENCE SENSOR is OLO.

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Other records listing Orthalign, Inc. as applicant

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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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