The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Skeletal Dynamics Forearm Plating System.
| Device ID | K200538 |
| 510k Number | K200538 |
| Device Name: | Skeletal Dynamics Forearm 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 | 2020-03-03 |
| Decision Date | 2020-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841506115887 | K200538 | 000 |
| 00841506108827 | K200538 | 000 |
| 00841506108858 | K200538 | 000 |
| 00841506109152 | K200538 | 000 |
| 00841506112732 | K200538 | 000 |
| 00841506112992 | K200538 | 000 |
| 00841506113012 | K200538 | 000 |
| 00841506114576 | K200538 | 000 |
| 00841506114583 | K200538 | 000 |
| 00841506114590 | K200538 | 000 |
| 00841506115375 | K200538 | 000 |
| 00841506115382 | K200538 | 000 |
| 00841506115399 | K200538 | 000 |
| 00841506115740 | K200538 | 000 |
| 00841506114705 | K200538 | 000 |