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FDA 510(k)

CEMENT SPACERS

K-Number: K791351 · 1979-08-03

ApplicantDepuy, Inc.
Decision Date1979-08-03
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CEMENT SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K791351. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENT SPACERS?

CEMENT SPACERS is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Depuy, Inc.. The 510(k) number is K791351.

When did CEMENT SPACERS receive FDA 510(k) clearance?

CEMENT SPACERS received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791351.

Who is the listed applicant for CEMENT SPACERS?

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 CEMENT SPACERS?

The FDA product code for CEMENT SPACERS is KYB.

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Other records listing Depuy, Inc. as applicant

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K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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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