510(k) K770161
K770161 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "MICROFENESTRATED HIP REPLACEMENT COMPON.". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Medishield, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1977
- Date Received
- January 24, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type