The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Neon3™ Universal Oct Spinal Stabilization.
| Device ID | K161032 |
| 510k Number | K161032 |
| Device Name: | Neon3™ Universal OCT Spinal Stabilization |
| Classification | Posterior Cervical Screw System |
| Applicant | ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm, DE 89081 |
| Contact | Christoph Ulrich |
| Correspondent | Hans Stover ULRICH MEDICAL USA 18221 EDISON AVENUE Chesterfield, MO 63005 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-12-22 |
| Summary: | summary |