The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Polaris Spinal Growth System.
| Device ID | K180227 |
| 510k Number | K180227 |
| Device Name: | Polaris Spinal Growth System |
| Classification | Growing Rod System |
| Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | Anthony Michael Maahs |
| Correspondent | Anthony Maahs Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | PGM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-26 |
| Decision Date | 2018-03-15 |
| Summary: | summary |