The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Foot And Ankle Plating System.
Device ID | K172973 |
510k Number | K172973 |
Device Name: | Life Spine Foot And Ankle Plating System |
Classification | Plate, Fixation, Bone |
Applicant | Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
Contact | Randy Lewis |
Correspondent | Randy Lewis Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-26 |
Decision Date | 2017-12-21 |
Summary: | summary |