510(k) K003618

Device

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014

Applicant

Whiteside Biomechanics, Inc.

510(k) number

K003618

Product code

NDD

Decision

Substantially Equivalent (SESE)

Decision date

2001-05-23

Date received

2000-11-22

Regulation

888.3010

Classification name

Cerclage, Fixation, Metallic

Medical specialty

Orthopedic

Review panel

Orthopedic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N