The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Zyston Arc Interbody Spacer.
| Device ID | K110650 |
| 510k Number | K110650 |
| Device Name: | ZYSTON ARC INTERBODY SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-06-30 |
| Summary: | summary |