The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Flap Twist Clamp.
| Device ID | K991860 |
| 510k Number | K991860 |
| Device Name: | SYNTHES CRANIAL FLAP TWIST CLAMP |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-07-20 |
| Summary: | summary |