Submission Details
| 510(k) Number | K202016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 21, 2020 |
| Decision Date | October 16, 2020 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Dall-Miles? Cable System
Oct 2020
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K202016 is an FDA 510(k) clearance for the Dall-Miles? Cable System, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on October 16, 2020, 87 days after receiving the submission on July 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.
Device Classification
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3010 |
Manufacturer
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Malwah, NJ · US
Margaret Klippel
31 submissions
31 cleared
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