The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Calcaneal Plate And Screw Fixation System.
| Device ID | K071105 |
| 510k Number | K071105 |
| Device Name: | OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Dawn D Tindall |
| Correspondent | Dawn D Tindall 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 | 2007-04-19 |
| Decision Date | 2007-07-30 |
| Summary: | summary |