The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Sternal Fixation System.
| Device ID | K052683 |
| 510k Number | K052683 |
| Device Name: | SYNTHES (USA) STERNAL FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980460046S0 | K052683 | 000 |
| H9804600460 | K052683 | 000 |
| H9804496210 | K052683 | 000 |
| H9804496120 | K052683 | 000 |