510(k) K191781
K191781 is an FDA 510(k) premarket notification submitted by Zimmer GmbH for the device "Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System". The FDA issued a decision of Substantially Equivalent on Aug 6, 2019. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Zimmer GmbH has 421 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2019
- Date Received
- Jul 2, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)