The following data is part of a premarket notification filed by Neos Surgery S.l. with the FDA for Cranial Loop Cranial Bone Fixation System.
| Device ID | K101235 |
| 510k Number | K101235 |
| Device Name: | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM |
| Classification | Cover, Burr Hole |
| Applicant | NEOS SURGERY S.L. 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Marcos Velez-duran |
| Correspondent | Marcos Velez-duran NEOS SURGERY S.L. 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-10-25 |
| Summary: | summary |