The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Spartan S3 Facet System.
| Device ID | K092568 |
| 510k Number | K092568 |
| Device Name: | SPARTAN S3 FACET SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | AMENDIA, INC. 13540 GUILD AVENUE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen AMENDIA, INC. 13540 GUILD AVENUE Apple Valley, MN 55124 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2009-11-17 |
| Summary: | summary |