The following data is part of a premarket notification filed by Conventus Orthopaedics with the FDA for Conventus Orthopaedics Fracture Fixation System.
| Device ID | K102689 |
| 510k Number | K102689 |
| Device Name: | CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | CONVENTUS ORTHOPAEDICS 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Hollace S Rhodes |
| Correspondent | Hollace S Rhodes CONVENTUS ORTHOPAEDICS 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-17 |
| Decision Date | 2013-01-17 |
| Summary: | summary |