The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Ensplintcmx Clavicle Pin.
| Device ID | K081832 |
| 510k Number | K081832 |
| Device Name: | ENSPLINTCMX CLAVICLE PIN |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER SUITE C Santa Rosa, CA 95403 |
| Contact | Charles Nelson |
| Correspondent | Charles Nelson SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER SUITE C Santa Rosa, CA 95403 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2008-10-10 |
| Summary: | summary |