The following data is part of a premarket notification filed by Suspension Orthopaedic Solutions, Llc with the FDA for Suspension Clavicle Fracture Repair System.
| Device ID | K113405 |
| 510k Number | K113405 |
| Device Name: | SUSPENSION CLAVICLE FRACTURE REPAIR 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 |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-01-11 |
| Summary: | summary |