510(k) K962002
K962002 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on August 8, 1996. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Exactech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1996
- Date Received
- May 22, 1996
- 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