K230850
- 510(k) number
- K230850
- Device name
- United Orthopedic Knee Patient Specific Instrumentation
- Applicant
- Enhatch, Inc. NJ · US
- Product code
- OOG — Knee Arthroplasty Implantation System
- Decision date
- 2023-12-20
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K230850.pdf
Official FDA record: K230850
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.