The following data is part of a premarket notification filed by Biomet Spine with the FDA for Zyston Straight Spacer System.
| Device ID | K112014 |
| 510k Number | K112014 |
| Device Name: | ZYSTON STRAIGHT SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Julie A Ryan |
| Correspondent | Julie A Ryan BIOMET SPINE 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 | 2011-07-14 |
| Decision Date | 2011-10-17 |
| Summary: | summary |