The following data is part of a premarket notification filed by Suspension Orthopaedic Solutions, Llc with the FDA for Suspension Clavicle Fracture Fixation System.
| Device ID | K112923 |
| 510k Number | K112923 |
| Device Name: | SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-12-27 |
| Summary: | summary |