The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Bone Screws.
Device ID | K150981 |
510k Number | K150981 |
Device Name: | SMV Scientific Bone Screws |
Classification | Screw, Fixation, Bone |
Applicant | SMV Scientific 111 Sandra Muraida Way Unit 18A Austin, TX 78703 |
Contact | Nephi Zufelt |
Correspondent | Nephi Zufelt SMV Scientific 111 Sandra Muraida Way Unit 18A Austin, TX 78703 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-14 |
Decision Date | 2015-06-23 |
Summary: | summary |