Product code OYK
- Device name
- Ankle Arthroplasty Implantation System
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3110
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
- Source
- FDA openFDA device classification dataset