510(k) K960363
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 by
Biomet, Inc.
— Product Code MJT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1997
- Date Received
- January 25, 1996
- Clearance Type
- Traditional
- 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