The following data is part of a premarket notification filed by Smv Scientific with the FDA for 4.0 And 6.5 Cancellous Bone Screw And Washer.
| Device ID | K160946 |
| 510k Number | K160946 |
| Device Name: | 4.0 And 6.5 Cancellous Bone Screw And Washer |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-12-05 |
| Summary: | summary |