The following data is part of a premarket notification filed by Spinal Acoustics, Llc with the FDA for Vstaar Adjuster.
| Device ID | K160278 |
| 510k Number | K160278 |
| Device Name: | VSTAAR AdjusteR |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | SPINAL ACOUSTICS, LLC 640 FOURTH STREET Beaver, PA 15009 |
| Contact | Albert A. Torrence |
| Correspondent | Albert A. Torrence SPINAL ACOUSTICS, LLC 640 FOURTH STREET Beaver, PA 15009 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-11-04 |
| Summary: | summary |