The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System.
| Device ID | K051293 |
| 510k Number | K051293 |
| Device Name: | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Tadeusz Wellisz |
| Correspondent | Tadeusz Wellisz CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2005-06-14 |
| Summary: | summary |