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FDA 510(k)

OMNIFIT DISTAL STEM CEMENT SPACERS

K-Number: K872528 · 1987-12-29

ApplicantOsteonics Corp.
Decision Date1987-12-29
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIFIT DISTAL STEM CEMENT SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K872528. 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 OMNIFIT DISTAL STEM CEMENT SPACERS?

OMNIFIT DISTAL STEM CEMENT SPACERS is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Osteonics Corp.. The 510(k) number is K872528.

When did OMNIFIT DISTAL STEM CEMENT SPACERS receive FDA 510(k) clearance?

OMNIFIT DISTAL STEM CEMENT SPACERS received FDA 510(k) clearance on 1987-12-29, under 510(k) number K872528.

Who is the listed applicant for OMNIFIT DISTAL STEM CEMENT SPACERS?

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 OMNIFIT DISTAL STEM CEMENT SPACERS?

The FDA product code for OMNIFIT DISTAL STEM CEMENT SPACERS is JDK.

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Other records listing Osteonics Corp. 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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Related Devices (Code: JDK)

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.

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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