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510k Database
Manufacturers
US
Std Mfg., Inc.
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Medical Device Manufacturer
·
US , Stoughton , MA
Std Mfg., Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1993
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Std Mfg., Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096
·
HSD
Orthopedic
·
204d
Cleared
Aug 01, 2002
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
K021549
·
KXA
Orthopedic
·
80d
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General & Plastic Surgery
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Orthopedic
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