K230850 is an FDA 510(k) clearance for the United Orthopedic Knee Patient Specific Instrumentation. This device is classified as a Knee Arthroplasty Implantation System (Class II - Special Controls, product code OOG).
Submitted by Enhatch, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 20, 2023, 267 days after receiving the submission on March 28, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560. 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..
| 510(k) Number | K230850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OOG - Knee Arthroplasty Implantation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |
| 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. |