Cleared Traditional

FPC/SFPC/RFPC ACETABULAR COMPONENT

K915529 · Implantology Corp. · Orthopedic

Jul 1993

Decision

581d

Days

Class 3

Risk

About This 510(k) Submission

K915529 is an FDA 510(k) clearance for the FPC/SFPC/RFPC 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 July 13, 1993, 581 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	K915529 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1991
Decision Date	July 13, 1993
Days to Decision	581 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