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FDA 510(k)

STRIDE UNICONDYLAR KNEE

K-Number: K123380 · 2013-05-31

ApplicantBlue Belt Technologies, Inc.
Decision Date2013-05-31
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRIDE UNICONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2013-05-31 under 510(k) number K123380. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRIDE UNICONDYLAR KNEE?

STRIDE UNICONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K123380.

When did STRIDE UNICONDYLAR KNEE receive FDA 510(k) clearance?

STRIDE UNICONDYLAR KNEE received FDA 510(k) clearance on 2013-05-31, under 510(k) number K123380.

Who is the listed applicant for STRIDE UNICONDYLAR KNEE?

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

What is the FDA product code for STRIDE UNICONDYLAR KNEE?

The FDA product code for STRIDE UNICONDYLAR KNEE is HSX.

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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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