OOG — Knee Arthroplasty Implantation System Class II
FDA product code OOG covers "Knee Arthroplasty Implantation System", a Class II medical device regulated under 21 CFR 888.3560. Submissions are reviewed by the Orthopedic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OOG
- Device Class
- Class II
- Regulation Number
- 888.3560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.