The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Cannulated Screw System.
| Device ID | K151021 |
| 510k Number | K151021 |
| Device Name: | OsteoMed Cannulated Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED CORP. 3885 Arapho Road Addison, TX 75001 |
| Contact | Blesson Abraham |
| Correspondent | Piedad Pena OSTEOMED CORP. 3885 Arapaho Road Addison, TX 75001 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2015-07-15 |
| Summary: | summary |