510(k) K131237
K131237 is an FDA 510(k) premarket notification submitted by Pipeline Orthopedics for the device "PIPELINE TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2013. 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. Pipeline Orthopedics has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2013
- Date Received
- May 1, 2013
- 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