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FDA 510(k)

ORTHOPEADIC CEMENT DELIVERY SYSTEM

K-Number: K851881 · 1985-06-13

ApplicantDentsply Intl.
Decision Date1985-06-13
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEADIC CEMENT DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K851881. 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 ORTHOPEADIC CEMENT DELIVERY SYSTEM?

ORTHOPEADIC CEMENT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Dentsply Intl.. The 510(k) number is K851881.

When did ORTHOPEADIC CEMENT DELIVERY SYSTEM receive FDA 510(k) clearance?

ORTHOPEADIC CEMENT DELIVERY SYSTEM received FDA 510(k) clearance on 1985-06-13, under 510(k) number K851881.

Who is the listed applicant for ORTHOPEADIC CEMENT DELIVERY SYSTEM?

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

What is the FDA product code for ORTHOPEADIC CEMENT DELIVERY SYSTEM?

The FDA product code for ORTHOPEADIC CEMENT DELIVERY SYSTEM is KIH.

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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.K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica 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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