The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Avenue P Cage System.
| Device ID | K181096 |
| 510k Number | K181096 |
| Device Name: | Avenue P Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Alex Pawlowski |
| Correspondent | Alex Pawlowski Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-26 |
| Decision Date | 2019-01-15 |
| Summary: | summary |