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FDA 510(k)

OSSEOCONDUCT

K-Number: K101718 · 2010-10-26

ApplicantSteiner Laboratories Div of Steiner Healthcare, LLC
Decision Date2010-10-26
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOCONDUCT is the device name listed in this FDA 510(k) record. The listed applicant is Steiner Laboratories Div of Steiner Healthcare, LLC. It received FDA 510(k) clearance on 2010-10-26 under 510(k) number K101718. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEOCONDUCT?

OSSEOCONDUCT is a medical device that received FDA 510(k) clearance on 2010-10-26. The listed applicant is Steiner Laboratories Div of Steiner Healthcare, LLC. The 510(k) number is K101718.

When did OSSEOCONDUCT receive FDA 510(k) clearance?

OSSEOCONDUCT received FDA 510(k) clearance on 2010-10-26, under 510(k) number K101718.

Who is the listed applicant for OSSEOCONDUCT?

The FDA 510(k) record lists Steiner Laboratories Div of Steiner Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSEOCONDUCT?

The FDA product code for OSSEOCONDUCT is LYC.

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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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