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FDA 510(k)

CEMENT RESTRICTOR, SMALL AND LARGE

K-Number: K021765 · 2002-08-16

ApplicantExactech, Inc.
Decision Date2002-08-16
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMENT RESTRICTOR, SMALL AND LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2002-08-16 under 510(k) number K021765. 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 CEMENT RESTRICTOR, SMALL AND LARGE?

CEMENT RESTRICTOR, SMALL AND LARGE is a medical device that received FDA 510(k) clearance on 2002-08-16. The listed applicant is Exactech, Inc.. The 510(k) number is K021765.

When did CEMENT RESTRICTOR, SMALL AND LARGE receive FDA 510(k) clearance?

CEMENT RESTRICTOR, SMALL AND LARGE received FDA 510(k) clearance on 2002-08-16, under 510(k) number K021765.

Who is the listed applicant for CEMENT RESTRICTOR, SMALL AND LARGE?

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

What is the FDA product code for CEMENT RESTRICTOR, SMALL AND LARGE?

The FDA product code for CEMENT RESTRICTOR, SMALL AND LARGE is JDK.

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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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