The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Internal Joint Stabilizer - Elbow.
| Device ID | K153208 |
| 510k Number | K153208 |
| Device Name: | Internal Joint Stabilizer - Elbow |
| Classification | Internal Hinged Elbow Fixator |
| Applicant | SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Contact | Ana M Escagedo |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | OZI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2015-12-31 |