The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Interbody Cages.
Device ID | K092193 |
510k Number | K092193 |
Device Name: | SPINAL USA INTERBODY CAGES |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
Contact | Jeffrey Johnson |
Correspondent | Jeffrey Johnson SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-21 |
Decision Date | 2009-09-25 |
Summary: | summary |