The following data is part of a premarket notification filed by Conventus Orthopaedics, Inc. with the FDA for Conventus Phs System.
Device ID | K141737 |
510k Number | K141737 |
Device Name: | CONVENTUS PHS SYSTEM |
Classification | Nail, Fixation, Bone |
Applicant | CONVENTUS ORTHOPAEDICS, INC. 10200 73RD AVE. N, STE 122 Maple Grove, MN 55369 |
Contact | Kent Lind |
Correspondent | Kent Lind CONVENTUS ORTHOPAEDICS, INC. 10200 73RD AVE. N, STE 122 Maple Grove, MN 55369 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-27 |
Decision Date | 2015-04-08 |
Summary: | summary |