The following data is part of a premarket notification filed by Acme Spine, Llc. with the FDA for Acme Spine System - Series 6000, 7000, Monoaxial And Polyaxial Screw System.
| Device ID | K001044 |
| 510k Number | K001044 |
| Device Name: | ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ACME SPINE, LLC. 9980 INDIANA AVE. UNIT 9 Riverside, CA 92503 |
| Contact | Timothy Williams |
| Correspondent | Timothy Williams ACME SPINE, LLC. 9980 INDIANA AVE. UNIT 9 Riverside, CA 92503 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-31 |
| Decision Date | 2000-11-03 |