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510(k) K930833

PCA(R) SOLID BACK ACETABULA SHELL by Howmedica Corp. — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
February 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

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  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)