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FDA 510(k)

ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM

K-Number: K121651 · 2012-10-12

ApplicantWrightmedicaltechnologyinc
Decision Date2012-10-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K121651. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM?

ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K121651.

When did ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM receive FDA 510(k) clearance?

ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM received FDA 510(k) clearance on 2012-10-12, under 510(k) number K121651.

Who is the listed applicant for ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM?

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

What is the FDA product code for ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM?

The FDA product code for ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM is HRS.

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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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