Vario-Cup System
FDA 510(k) clearance K221794 · decided 2022-07-20
Clearance details
- K-number
- K221794
- Device name
- Vario-Cup System
- Applicant
- Waldemar Link GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2022-06-21
- Decision date
- 2022-07-20
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Norderstedt, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.