510(k) K230850
K230850 is an FDA 510(k) premarket notification submitted by Enhatch, Inc. for the device "United Orthopedic Knee Patient Specific Instrumentation". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code OOG (Knee Arthroplasty Implantation System), a Class II device regulated under 21 CFR 888.3560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2023
- Date Received
- March 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Knee Arthroplasty Implantation System
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
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.