FDA 510(k)

PCA(R) SOLID BACK ACETABULA SHELL

K-Number: K930833 · 1994-02-22

Decision Date1994-02-22

Product CodeJDL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PCA(R) SOLID BACK ACETABULA SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K930833. 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(R) SOLID BACK ACETABULA SHELL?

PCA(R) SOLID BACK ACETABULA SHELL is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Howmedica Corp.. The 510(k) number is K930833.

When did PCA(R) SOLID BACK ACETABULA SHELL receive FDA 510(k) clearance?

PCA(R) SOLID BACK ACETABULA SHELL received FDA 510(k) clearance on 1994-02-22, under 510(k) number K930833.

Who is the listed applicant for PCA(R) SOLID BACK ACETABULA SHELL?

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(R) SOLID BACK ACETABULA SHELL?

The FDA product code for PCA(R) SOLID BACK ACETABULA SHELL is JDL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 373 devices →

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.