Proprietary Name: |
AperFix® Tibial Implant 8mmx30mm - CM-3008; AperFix®II Cannulated Tibial 10mmx30mm - CM-3010C; AperFix®II Cannulated Tibial 11mmx30mm - CM-3011C; AperFix®II Cannulated Tibial 9mmx30mm - CM-3009C |
Classification Name: |
SCREW, FIXATION, BONE |
Product Code: |
HWC |
Device Class: |
2 |
Regulation Number: |
888.3040 |
Medical Specialty: |
Orthopedic |
Registered Establishment Name: |
CAYENNE MEDICAL, INC.
|
Registered Establishment Number: |
3006108336
|
Premarket Submission Number: |
K083607 |
Owner/Operator: |
CAYENNE MEDICAL, INC. |
Owner/Operator Number: |
9091610
|
Establishment Operations: |
Manufacturer
|
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