510(k) K162125
K162125 is an FDA 510(k) premarket notification submitted by Surgtech, Inc. for the device "MALUC Total Hip Arthroplasty System". The FDA issued a decision of Substantially Equivalent on May 10, 2017. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Surgtech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2017
- Date Received
- August 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type