Cleared Traditional

CPS ACETABULAR COMPONENT

K915527 · Implantology Corp. · Orthopedic

Jun 1993

Decision

562d

Days

Class 3

Risk

About This 510(k) Submission

K915527 is an FDA 510(k) clearance for the CPS ACETABULAR COMPONENT, a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL), submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on June 24, 1993, 562 days after receiving the submission on December 10, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K915527 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1991
Decision Date	June 24, 1993
Days to Decision	562 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3320