The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Bone Plate And Screw System.
| Device ID | K152000 |
| 510k Number | K152000 |
| Device Name: | SMV Scientific Bone Plate And Screw System |
| Classification | Plate, Fixation, Bone |
| Applicant | SMV Scientific 111 Sandra Muraida Way Unit 18A Austin, TX 78703 |
| Contact | Nephi Zufelt |
| Correspondent | Kenneth C Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-20 |
| Decision Date | 2015-11-25 |
| Summary: | summary |