The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Low Profile Neuro Fixation System.
| Device ID | K111176 |
| 510k Number | K111176 |
| Device Name: | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2011-08-15 |
| Summary: | summary |