FDA 510(k)

OSSE-LIGN

K-Number: K023564 · 2003-03-11

Decision Date2003-03-11

Product CodeJDQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSSE-LIGN is the device name listed in this FDA 510(k) record. The listed applicant is Osseus, LLC. It received FDA 510(k) clearance on 2003-03-11 under 510(k) number K023564. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSE-LIGN?

OSSE-LIGN is a medical device that received FDA 510(k) clearance on 2003-03-11. The listed applicant is Osseus, LLC. The 510(k) number is K023564.

When did OSSE-LIGN receive FDA 510(k) clearance?

OSSE-LIGN received FDA 510(k) clearance on 2003-03-11, under 510(k) number K023564.

Who is the listed applicant for OSSE-LIGN?

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

What is the FDA product code for OSSE-LIGN?

The FDA product code for OSSE-LIGN is JDQ.

Other records listing Osseus, LLC 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.

K040199OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS

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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.