Submission Details
| 510(k) Number | K171911 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2017 |
| Decision Date | November 09, 2017 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Medline ReNewal Reprocessed Synthes External Fixation Systems
Nov 2017
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K171911 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Synthes External Fixation Systems, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on November 9, 2017, 136 days after receiving the submission on June 26, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
Surgical Instrument Service and Savings, Inc.
Redmond, OR · US
Stephanie Boyle Mays
23 submissions
23 cleared
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