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FDA 510(k)

OSTEONICS SCREW HOLE PLUGS

K-Number: K965056 · 1997-02-28

ApplicantOsteonics Corp.
Decision Date1997-02-28
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEONICS SCREW HOLE PLUGS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K965056. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS SCREW HOLE PLUGS?

OSTEONICS SCREW HOLE PLUGS is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Osteonics Corp.. The 510(k) number is K965056.

When did OSTEONICS SCREW HOLE PLUGS receive FDA 510(k) clearance?

OSTEONICS SCREW HOLE PLUGS received FDA 510(k) clearance on 1997-02-28, under 510(k) number K965056.

Who is the listed applicant for OSTEONICS SCREW HOLE PLUGS?

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

What is the FDA product code for OSTEONICS SCREW HOLE PLUGS?

The FDA product code for OSTEONICS SCREW HOLE PLUGS is JDK.

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Other records listing Osteonics Corp. as applicant

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Related Devices (Code: JDK)

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K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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