The following data is part of a premarket notification filed by Zimmer Biomet Spine Inc. with the FDA for Zyston Strut Open Titanium Spacer System.
| Device ID | K171495 |
| 510k Number | K171495 |
| Device Name: | Zyston Strut Open Titanium Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Biomet Spine Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Megan Fessenden |
| Correspondent | Megan Fessenden Zimmer Biomet Spine Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-22 |
| Decision Date | 2018-02-12 |
| Summary: | summary |