The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes External Fixation Bone Clip.
| Device ID | K894098 |
| 510k Number | K894098 |
| Device Name: | SYNTHES EXTERNAL FIXATION BONE CLIP |
| Classification | Component, Traction, Invasive |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Susan M Snyder |
| Correspondent | Susan M Snyder SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-09 |
| Decision Date | 1990-04-30 |