The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes] Mini External Fixator.
| Device ID | K971987 |
| 510k Number | K971987 |
| Device Name: | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-06-24 |