The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Extremilock Wrist Plating System.
| Device ID | K161041 |
| 510k Number | K161041 |
| Device Name: | OsteoMed ExtremiLOCK Wrist Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Contact | Kathryn Jayne |
| Correspondent | Kathryn Jayne OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-05-19 |
| Summary: | summary |