The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Vsp (variable Screw Placement) Spinal Fixation System, Pedicle Screw(s), Spine Plate(s), Washer(s) & Nut(s).
| Device ID | K951657 |
| 510k Number | K951657 |
| Device Name: | VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Gregory Cannedy |
| Correspondent | Gregory Cannedy ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| 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 | 1995-04-10 |
| Decision Date | 1995-08-21 |