The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Cannulated Screws.
Device ID | K150126 |
510k Number | K150126 |
Device Name: | Life Spine Cannulated Screws |
Classification | Screw, 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 | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-20 |
Decision Date | 2015-05-11 |
Summary: | summary |