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 |