510(k) K120599
K120599 is an FDA 510(k) premarket notification submitted by Depuy Orthopaedics for the device "DEPUY M-SPEC 36MM FEMORAL HEADS". The FDA issued a decision of Substantially Equivalent on April 30, 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. Depuy Orthopaedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2013
- Date Received
- February 28, 2012
- 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