The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber™ Hammertoe Fixation System/ossiofiber™ Hammertoe Fixation Implant.
Device ID | K201803 |
510k Number | K201803 |
Device Name: | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant |
Classification | Pin, Fixation, Smooth |
Applicant | Ossio Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
Contact | Taly Lindner |
Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-30 |
Decision Date | 2020-10-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |