JOURNEY II UK and ENGAGE Cementless Partial Knee System— 510(k) K222653
Substantially EquivalentSmith+Nephew, Inc.
FDA 510(k) clearance K222653 for JOURNEY II UK and ENGAGE Cementless Partial Knee System, Substantially Equivalent on 2022-10-28. Applicant: Smith+Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith+Nephew, Inc.
- Product code
- Product code NJD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3535
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.