The following data is part of a premarket notification filed by Life Spine with the FDA for Plateau Spacer System.
Device ID | K111569 |
510k Number | K111569 |
Device Name: | PLATEAU SPACER SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Contact | Randy Lewis |
Correspondent | Randy Lewis LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-06 |
Decision Date | 2011-07-06 |
Summary: | summary |