Dall-Miles® Cable System

Cerclage, Fixation

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

The following data is part of a premarket notification filed by Howmedica Osteonics Corp., Dba Stryker Orthopaedics with the FDA for Dall-miles® Cable System.

Pre-market Notification Details

• Device ID: K202016
• 510k Number: K202016
• Device Name: Dall-Miles® Cable System
• Classification: Cerclage, Fixation
• Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430
• Contact: Margaret Klippel
• Correspondent: Margaret Klippel; Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430
• Product Code: JDQ
• Subsequent Product Code: HRS
• Subsequent Product Code: LRN
• Subsequent Product Code: LYT
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-21
• Decision Date: 2020-10-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327036497	K202016	000
07613327036367	K202016	000
07613327036350	K202016	000
07613327036343	K202016	000
07613327036336	K202016	000
07613327013320	K202016	000
07613327013313	K202016	000
07613327013306	K202016	000
07613327013344	K202016	000
07613327013351	K202016	000
07613327036374	K202016	000
07613327036381	K202016	000
07613327036398	K202016	000
07613327036480	K202016	000
07613327036473	K202016	000
07613327036466	K202016	000
07613327036459	K202016	000
07613327036442	K202016	000
07613327036435	K202016	000
07613327036428	K202016	000
07613327036411	K202016	000
07613327036404	K202016	000
07613327013337	K202016	000