The following data is part of a premarket notification filed by Osteomed Llc with the FDA for Osteomed Extremifix Mid And Large Screw System.
| Device ID | K163303 |
| 510k Number | K163303 |
| Device Name: | OsteoMed ExtremiFix Mid And Large Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | OsteoMed LLC 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Ellen Hong |
| Correspondent | Kathryn Jayne OsteoMed LLC 3885 Arapaho Rd Addison, TX 75001 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-04-04 |
| Summary: | summary |