The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Geminus Volar Distal Radius Plate System.
| Device ID | K182492 |
| 510k Number | K182492 |
| Device Name: | Geminus Volar Distal Radius Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Skeletal Dynamics, LLC 7300 North Kendall Drive, Suite 400 Miami, FL 33156 |
| Contact | Ana M. Escagedo |
| Correspondent | Ana M. Escagedo Skeletal Dynamics, LLC 7300 North Kendall Drive, Suite 400 Miami, FL 33156 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841506109961 | K182492 | 000 |
| 00841506107370 | K182492 | 000 |
| 00841506107387 | K182492 | 000 |
| 00841506107394 | K182492 | 000 |
| 00841506107400 | K182492 | 000 |
| 00841506107417 | K182492 | 000 |
| 00841506107424 | K182492 | 000 |
| 00841506107431 | K182492 | 000 |
| 00841506107448 | K182492 | 000 |
| 00841506107455 | K182492 | 000 |
| 00841506107462 | K182492 | 000 |
| 00841506107479 | K182492 | 000 |
| 00841506107486 | K182492 | 000 |
| 00841506107493 | K182492 | 000 |
| 00841506107509 | K182492 | 000 |
| 00841506109121 | K182492 | 000 |
| 00841506107363 | K182492 | 000 |