The following data is part of a premarket notification filed by Tasarimmed Tibbi Mamuller Sanayi Ve Ticaret A.s with the FDA for Spider Frame External Fixation System.
| Device ID | K170482 |
| 510k Number | K170482 |
| Device Name: | Spider Frame External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S Demirkapi Topcular Mahallesi Topcular Caddesi Set Ustu No:3 Istanbul, TR Tr 34055 |
| Contact | Sumru Alperen |
| Correspondent | Sumru Alperen TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S Demirkapi Topcular Mahallesi Topcular Caddesi Set Ustu No:3 Istanbul, TR Tr 34055 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-09-27 |