The following data is part of a premarket notification filed by Icon Orthopedic Concepts, Llc Dba Edge Orthopaedic with the FDA for View Plating System,reduce Fracture Plating System,bone Screw.
| Device ID | K140876 |
| 510k Number | K140876 |
| Device Name: | VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC 6 MARS COURT, UNIT 6-3 Boonton, NJ 07005 |
| Contact | Jan Triani |
| Correspondent | Jan Triani ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC 6 MARS COURT, UNIT 6-3 Boonton, NJ 07005 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-07 |
| Decision Date | 2014-07-22 |
| Summary: | summary |