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FDA 510(k)

ORTHOSLENDERIZER

K-Number: K111249 · 2012-02-08

ApplicantOrthomatics, Inc.
Decision Date2012-02-08
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOSLENDERIZER is the device name listed in this FDA 510(k) record. The listed applicant is Orthomatics, Inc.. It received FDA 510(k) clearance on 2012-02-08 under 510(k) number K111249. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSLENDERIZER?

ORTHOSLENDERIZER is a medical device that received FDA 510(k) clearance on 2012-02-08. The listed applicant is Orthomatics, Inc.. The 510(k) number is K111249.

When did ORTHOSLENDERIZER receive FDA 510(k) clearance?

ORTHOSLENDERIZER received FDA 510(k) clearance on 2012-02-08, under 510(k) number K111249.

Who is the listed applicant for ORTHOSLENDERIZER?

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

What is the FDA product code for ORTHOSLENDERIZER?

The FDA product code for ORTHOSLENDERIZER is EFB.

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Related Devices (Code: EFB)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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