The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Skeletal Dynamics Ulnar Shortening Plating System.
| Device ID | K201962 |
| 510k Number | K201962 |
| Device Name: | Skeletal Dynamics Ulnar Shortening 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 | 2020-07-15 |
| Decision Date | 2020-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841507516201 | K201962 | 000 |
| 00841506117577 | K201962 | 000 |
| 00841506117560 | K201962 | 000 |
| 00841506116204 | K201962 | 000 |
| 00841506116136 | K201962 | 000 |
| 00841506116129 | K201962 | 000 |
| 00841506116112 | K201962 | 000 |
| 00841506116105 | K201962 | 000 |
| 00841506116099 | K201962 | 000 |
| 00841506116082 | K201962 | 000 |
| 00841506116075 | K201962 | 000 |
| 00841506116068 | K201962 | 000 |
| 00841506114446 | K201962 | 000 |
| 00841506114439 | K201962 | 000 |
| 00841506117614 | K201962 | 000 |
| 00841506130705 | K201962 | 000 |
| 00841506109985 | K201962 | 000 |
| 00841507516195 | K201962 | 000 |
| 00841507416181 | K201962 | 000 |
| 00841507316177 | K201962 | 000 |
| 00841507216163 | K201962 | 000 |
| 00841506916132 | K201962 | 000 |
| 00841506516097 | K201962 | 000 |
| 00841506416083 | K201962 | 000 |
| 00841506316666 | K201962 | 000 |
| 00841506316079 | K201962 | 000 |
| 00841506216065 | K201962 | 000 |
| 00841506116051 | K201962 | 000 |
| 00841506116037 | K201962 | 000 |
| 00841506115757 | K201962 | 000 |
| 00841506117690 | K201962 | 000 |