The following data is part of a premarket notification filed by Conventus Orthopaedics, Inc with the FDA for Conventus Prs System.
| Device ID | K151379 |
| 510k Number | K151379 |
| Device Name: | Conventus PRS System |
| Classification | Plate, Fixation, Bone |
| Applicant | Conventus Orthopaedics, Inc 10200 73rd Avenue North, Suite 122 Maple Grove, MN 55369 |
| Contact | Kent R Lind |
| Correspondent | Kent R Lind Conventus Orthopaedics, Inc 10200 73rd Avenue North, Suite 122 Maple Grove, MN 55369 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-22 |
| Decision Date | 2015-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814289020761 | K151379 | 000 |
| 00814289020754 | K151379 | 000 |