The following data is part of a premarket notification filed by Suspension Orthopaedic Solutions, Llc with the FDA for Suspension Acromioclavicular (ac) Repair System.
| Device ID | K102143 |
| 510k Number | K102143 |
| Device Name: | SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-12-08 |
| Summary: | summary |