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FDA 510(k)

BONE CEMENT APPLICATOR

K-Number: K780266 · 1978-02-28

ApplicantZimmer, Inc.
Decision Date1978-02-28
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE CEMENT APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1978-02-28 under 510(k) number K780266. 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 BONE CEMENT APPLICATOR?

BONE CEMENT APPLICATOR is a medical device that received FDA 510(k) clearance on 1978-02-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K780266.

When did BONE CEMENT APPLICATOR receive FDA 510(k) clearance?

BONE CEMENT APPLICATOR received FDA 510(k) clearance on 1978-02-28, under 510(k) number K780266.

Who is the listed applicant for BONE CEMENT APPLICATOR?

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

What is the FDA product code for BONE CEMENT APPLICATOR?

The FDA product code for BONE CEMENT APPLICATOR is KIH.

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Other records listing Zimmer, 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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