510(k) K171962
K171962 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Klassic HD® Hip System". The FDA issued a decision of Substantially Equivalent on Jul 24, 2017. 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. Total Joint Othopedics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2017
- Date Received
- Jun 30, 2017
- 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