The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Schanz Screws.
| Device ID | K160603 |
| 510k Number | K160603 |
| Device Name: | SMV Scientific Schanz 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 | 2016-03-02 |
| Decision Date | 2016-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816950024061 | K160603 | 000 |
| 00816950021602 | K160603 | 000 |
| 00816950021596 | K160603 | 000 |
| 00816950021589 | K160603 | 000 |
| 00816950021572 | K160603 | 000 |
| 00816950021565 | K160603 | 000 |
| 00816950021558 | K160603 | 000 |
| 00816950029707 | K160603 | 000 |
| 00816950029691 | K160603 | 000 |
| 00816950029684 | K160603 | 000 |
| 00816950029677 | K160603 | 000 |
| 00816950029660 | K160603 | 000 |
| 00816950029653 | K160603 | 000 |
| 00816950029646 | K160603 | 000 |
| 00816950029639 | K160603 | 000 |
| 00816950029622 | K160603 | 000 |
| 00816950029615 | K160603 | 000 |
| 00816950029608 | K160603 | 000 |
| 00816950021619 | K160603 | 000 |
| 00816950021626 | K160603 | 000 |
| 00816950021794 | K160603 | 000 |
| 00816950021787 | K160603 | 000 |
| 00816950021770 | K160603 | 000 |
| 00816950021763 | K160603 | 000 |
| 00816950021756 | K160603 | 000 |
| 00816950021749 | K160603 | 000 |
| 00816950021732 | K160603 | 000 |
| 00816950021725 | K160603 | 000 |
| 00816950021718 | K160603 | 000 |
| 00816950021701 | K160603 | 000 |
| 00816950021695 | K160603 | 000 |
| 00816950021688 | K160603 | 000 |
| 00816950021671 | K160603 | 000 |
| 00816950021664 | K160603 | 000 |
| 00816950021657 | K160603 | 000 |
| 00816950021640 | K160603 | 000 |
| 00816950021633 | K160603 | 000 |
| 00816950029592 | K160603 | 000 |