510(k) K003801
K003801 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "ANATOMICAL PRESS-FIT HUMERAL STEM". The FDA issued a decision of Substantially Equivalent on February 28, 2001. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2001
- Date Received
- December 8, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type