The following data is part of a premarket notification filed by Met 1 Technologies, Llc with the FDA for Virtu Lumbar Spacer System.
| Device ID | K160699 |
| 510k Number | K160699 |
| Device Name: | VIRTU Lumbar Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Met 1 Technologies, LLC 154 N. Festival Dr., Ste. F El Paso, TX 79912 |
| Contact | Dan Gerbec |
| Correspondent | Kenneth C. Maxwell Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-14 |
| Decision Date | 2016-08-01 |
| Summary: | summary |