The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec Osteo-plate And Screw Fixation.
| Device ID | K092889 |
| 510k Number | K092889 |
| Device Name: | SYNTEC OSTEO-PLATE AND SCREW FIXATION |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei, TW 106 |
| Contact | Carol Chang |
| Correspondent | Carol Chang SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei, TW 106 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-06-25 |
| Summary: | summary |