FDA 510(k)

PCA ACETABULAR INSERT II

K-Number: K921384 · 1992-06-25

Decision Date1992-06-25

Product CodeJDL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PCA ACETABULAR INSERT II is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K921384. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCA ACETABULAR INSERT II?

PCA ACETABULAR INSERT II is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Howmedica Corp.. The 510(k) number is K921384.

When did PCA ACETABULAR INSERT II receive FDA 510(k) clearance?

PCA ACETABULAR INSERT II received FDA 510(k) clearance on 1992-06-25, under 510(k) number K921384.

Who is the listed applicant for PCA ACETABULAR INSERT II?

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

What is the FDA product code for PCA ACETABULAR INSERT II?

The FDA product code for PCA ACETABULAR INSERT II is JDL.

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Other records listing Howmedica Corp. as applicant

K983528MICRO DYNAMIC MESH K983404TYPE 3 FEMORAL COMPONENTS K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: JDL)

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyinc K061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyinc K051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyinc K051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyinc K042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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.