510(k) K223318
- Device
- Internal Joint Stabilizer - Elbow
- Applicant
- Skeletal Dynamics, Inc.
- 510(k) number
- K223318
- Product code
- OZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-10
- Date received
- 2022-10-28
- Regulation
- 888.3030
- Classification name
- Internal Hinged Elbow Fixator
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alexandra Rodriguez Rojas
- Address
- 7300 N. Kendall Dr. Suite 400 Miami FL US 33156 33156
FDA Registration Numbers#
- 3006742481
- 3007993775
- 2183946
- 3014680795
- 3006783837