510(k) K112150
K112150 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROFEMUR GLADIATOR HA HIP STEM". The FDA issued a decision of Substantially Equivalent on November 23, 2011. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2011
- Date Received
- July 27, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device Class
- Class III
- Regulation Number
- 888.3330
- Review Panel
- OR
- Submission Type