510(k) K014049
K014049 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "EPOCA CODR STEM AND HEAD". The FDA issued a decision of Substantially Equivalent on January 9, 2002. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Stelkast Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2002
- Date Received
- December 10, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3650
- Review Panel
- OR
- Submission Type