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FDA 510(k)

ORTHO-1(NOT FINALIZED)

K-Number: K113401 · 2012-02-07

ApplicantBisco, Inc.
Decision Date2012-02-07
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-1(NOT FINALIZED) is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2012-02-07 under 510(k) number K113401. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-1(NOT FINALIZED)?

ORTHO-1(NOT FINALIZED) is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is Bisco, Inc.. The 510(k) number is K113401.

When did ORTHO-1(NOT FINALIZED) receive FDA 510(k) clearance?

ORTHO-1(NOT FINALIZED) received FDA 510(k) clearance on 2012-02-07, under 510(k) number K113401.

Who is the listed applicant for ORTHO-1(NOT FINALIZED)?

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

What is the FDA product code for ORTHO-1(NOT FINALIZED)?

The FDA product code for ORTHO-1(NOT FINALIZED) is DYH.

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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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