510(k) K171768
K171768 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Trident® II Acetabular System". The FDA issued a decision of Substantially Equivalent on October 2, 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. Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2017
- Date Received
- June 14, 2017
- Clearance Type
- Traditional
- 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