LINK GEMINI SL Total Knee System
FDA 510(k) clearance K182872 · decided 2019-04-03
Clearance details
- K-number
- K182872
- Device name
- LINK GEMINI SL Total Knee System
- Applicant
- Waldemar Link GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2018-10-12
- Decision date
- 2019-04-03
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- 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.