510(k) K191755
K191755 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "SPAR-K Instruments (for use with Gemini SL Total Knee System)". The FDA issued a decision of Substantially Equivalent on Jul 18, 2019. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Waldemar Link GmbH & Co. KG has 42 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 18, 2019
- Date Received
- Jul 1, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
- 510(k)