The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Dorsal Spanning Plate.
| Device ID | K150675 |
| 510k Number | K150675 |
| Device Name: | Dorsal Spanning Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Contact | Ann M. Escagedo |
| Correspondent | Ann M. Escagedo SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-05-12 |
| Summary: | summary |