The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Synthes External Fixation Systems.
| Device ID | K171911 |
| 510k Number | K171911 |
| Device Name: | Medline ReNewal Reprocessed Synthes External Fixation Systems |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Contact | Stephanie Boyle Mays |
| Correspondent | Stephanie Boyle Mays Surgical Instrument Service And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888277692466 | K171911 | 000 |
| 10888277692459 | K171911 | 000 |
| 10080196692477 | K171911 | 000 |