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 |