PAEClass II
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
Physical Medicine · 21 CFR 890.3450
Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.
MDR events4All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
4 adverse event reports on file
- UNKNOWN POLY COMPONENTNov 30, 2018InjuryZimmer Biomet, Inc.0001822565-2018-06667
- UNKNOWN POLY COMPONENTNov 30, 2018InjuryZimmer Biomet, Inc.0001822565-2018-06668
- UNKNOWN ULNAFeb 20, 2018InjuryZimmer Biomet, Inc.0001822565-2018-00995
- C/M ELBOW ULNARFeb 16, 2018InjuryZimmer Biomet, Inc.0001822565-2018-00974
Event type breakdown
Injury4
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code