The following data is part of a premarket notification filed by Summit Medventures with the FDA for Smv Scientific 4.5 Mm Bone Screws.
| Device ID | K150188 |
| 510k Number | K150188 |
| Device Name: | SMV Scientific 4.5 Mm Bone Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | SUMMIT MEDVENTURES 111 SANDRA MURAIDA WAY, UNIT 18A Austin, TX 78703 |
| Contact | Nephi Zufelt |
| Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORP. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-04-29 |
| Summary: | summary |