The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Ghost Spacer System.
Device ID | K213417 |
510k Number | K213417 |
Device Name: | Ghost Spacer System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142 |
Contact | Angela Batker |
Correspondent | Angela Batker Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-10-20 |
Decision Date | 2022-09-29 |