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FDA 510(k)

GUN, CEMENT

K-Number: K781955 · 1978-12-04

ApplicantDepuy, Inc.
Decision Date1978-12-04
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GUN, CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781955. The device is classified under product code KIH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUN, CEMENT?

GUN, CEMENT is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Depuy, Inc.. The 510(k) number is K781955.

When did GUN, CEMENT receive FDA 510(k) clearance?

GUN, CEMENT received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781955.

Who is the listed applicant for GUN, CEMENT?

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

What is the FDA product code for GUN, CEMENT?

The FDA product code for GUN, CEMENT is KIH.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: KIH)

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.

K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.

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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