The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Wrist Arthrodesis Nail System.
| Device ID | K092720 |
| 510k Number | K092720 |
| Device Name: | WRIST ARTHRODESIS NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SKELETAL DYNAMICS, LLC 80 SHELDON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary SKELETAL DYNAMICS, LLC 80 SHELDON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2010-06-29 |
| Summary: | summary |