The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Smith & Nephew Jet-x External Fixation Devices.
| Device ID | K180580 |
| 510k Number | K180580 |
| Device Name: | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices |
| 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 | 2018-03-05 |
| Decision Date | 2018-07-27 |
| Summary: | summary |