Cleared Traditional

K920929 - POLY INSERT 20 DEGREE
(FDA 510(k) Clearance)

K920929 · Dow Corning Wright · Orthopedic

May 1993

Decision

432d

Days

Class 3

Risk

K920929 is an FDA 510(k) clearance for the POLY INSERT 20 DEGREE. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL).

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on May 5, 1993, 432 days after receiving the submission on February 28, 1992.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K920929 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 1992
Decision Date	May 05, 1993
Days to Decision	432 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