The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Stryker External Fixation Devices.
| Device ID | K163028 |
| 510k Number | K163028 |
| Device Name: | Medline ReNewal Reprocessed Stryker External Fixation Devices |
| Classification | Component, Traction, Invasive |
| Applicant | SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. Redmond, OR 97756 |
| Contact | Brandi J. Panteleon |
| Correspondent | Brandi J. Panteleon SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. Redmond, OR 97756 |
| Product Code | JEC |
| Subsequent Product Code | KTT |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2016-12-28 |
| Summary: | summary |