The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Cannulated Screws.
Device ID | K170021 |
510k Number | K170021 |
Device Name: | SMV Scientific Cannulated Screws |
Classification | Screw, Fixation, Bone |
Applicant | SMV Scientific 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 | 2017-01-03 |
Decision Date | 2017-05-22 |
Summary: | summary |