The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Hand Fusion System.
| Device ID | K111419 |
| 510k Number | K111419 |
| Device Name: | OSTEOMED HAND FUSION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-20 |
| Decision Date | 2011-10-07 |
| Summary: | summary |