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FDA 510(k)

SMARTTOOLS KNEE SYSTEM

K-Number: K122326 · 2012-11-30

ApplicantZimmer
Decision Date2012-11-30
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTTOOLS KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer. It received FDA 510(k) clearance on 2012-11-30 under 510(k) number K122326. 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 SMARTTOOLS KNEE SYSTEM?

SMARTTOOLS KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Zimmer. The 510(k) number is K122326.

When did SMARTTOOLS KNEE SYSTEM receive FDA 510(k) clearance?

SMARTTOOLS KNEE SYSTEM received FDA 510(k) clearance on 2012-11-30, under 510(k) number K122326.

Who is the listed applicant for SMARTTOOLS KNEE SYSTEM?

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

What is the FDA product code for SMARTTOOLS KNEE SYSTEM?

The FDA product code for SMARTTOOLS KNEE SYSTEM is OLO.

Related Clinical Trials

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Other records listing Zimmer 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.

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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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