The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Skeletal Dynamics Midshaft Humerus Plating System.
| Device ID | K200701 |
| 510k Number | K200701 |
| Device Name: | Skeletal Dynamics Midshaft Humerus Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841506129655 | K200701 | 000 |
| 00841506129679 | K200701 | 000 |
| 00841506129686 | K200701 | 000 |
| 00841506129709 | K200701 | 000 |
| 00841506129754 | K200701 | 000 |
| 00841506129839 | K200701 | 000 |
| 00841506129846 | K200701 | 000 |
| 00841506129853 | K200701 | 000 |
| 00841506129860 | K200701 | 000 |
| 00841506129877 | K200701 | 000 |
| 00841506129884 | K200701 | 000 |
| 00841506129891 | K200701 | 000 |
| 00841506129907 | K200701 | 000 |
| 00841506129914 | K200701 | 000 |
| 00841506129938 | K200701 | 000 |
| 00841506129952 | K200701 | 000 |
| 00841506129662 | K200701 | 000 |