K163028 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Stryker External Fixation Devices. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 28, 2016, 58 days after receiving the submission on October 31, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K163028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2016 |
| Decision Date | December 28, 2016 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC — Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |