510(k) K191936
K191936 is an FDA 510(k) premarket notification submitted by Thecken Companies, LLC for the device "iNSitu Total Hip System". The FDA issued a decision of Substantially Equivalent on Aug 20, 2019. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 2019
- Date Received
- Jul 19, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type
- 510(k)