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FDA 510(k)

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR

K-Number: K923616 · 1992-10-30

ApplicantOsteonics Corp.
Decision Date1992-10-30
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1992-10-30 under 510(k) number K923616. 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 OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR?

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1992-10-30. The listed applicant is Osteonics Corp.. The 510(k) number is K923616.

When did OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR receive FDA 510(k) clearance?

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR received FDA 510(k) clearance on 1992-10-30, under 510(k) number K923616.

Who is the listed applicant for OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR?

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 OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR?

The FDA product code for OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR 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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