The following data is part of a premarket notification filed by Ortho Solutions Limited with the FDA for Ortho Solutions Trauma Implants For Osteosynthesis.
Device ID | K110895 |
510k Number | K110895 |
Device Name: | ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS |
Classification | Screw, Fixation, Bone |
Applicant | ORTHO SOLUTIONS LIMITED 3150 E. 200TH STREET Prior Lake, MN 55372 |
Contact | Al Lippincott |
Correspondent | Al Lippincott ORTHO SOLUTIONS LIMITED 3150 E. 200TH STREET Prior Lake, MN 55372 |
Product Code | HWC |
Subsequent Product Code | HTN |
Subsequent Product Code | HTY |
Subsequent Product Code | JDQ |
Subsequent Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-30 |
Decision Date | 2011-12-19 |
Summary: | summary |