The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Neuro Rongeur.
| Device ID | K131851 |
| 510k Number | K131851 |
| Device Name: | OSTEOMED NEURO RONGEUR |
| Classification | Rongeur, Manual |
| Applicant | OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Contact | Piedad Pena, M.s. |
| Correspondent | Piedad Pena, M.s. OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2013-12-06 |
| Summary: | summary |