510(k) K982418
K982418 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "BUECHEL-PAPPAS MODULAR SALVAGE STEM". The FDA issued a decision of Substantially Equivalent on April 29, 1999. The device falls under product code MJT (Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented), a Class III device. Endotec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1999
- Date Received
- July 13, 1998
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class III
- Regulation Number
- Review Panel
- OR
- Submission Type