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489
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485
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444
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510k Database
Manufacturers
US
Poly-Medics,Inc.
Medical Device Manufacturer
·
US , Warsaw , IN
Poly-Medics,Inc. - FDA 510(k) Cleared Devices
5 submissions
·
1 cleared
·
Since 1994
5
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Poly-Medics,Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 10, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K960988
·
HRS
Orthopedic
·
34d
Cleared
Feb 14, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K955729
·
HRS
Orthopedic
·
58d
Cleared
Jan 31, 1996
LACTOSORB SUTURE ANCHOR
K954443
·
JDR
Orthopedic
·
128d
Cleared
Jul 25, 1995
LACTOSORB POP RIVET
K951658
·
JDR
Orthopedic
·
106d
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5
Orthopedic
4
General & Plastic Surgery
1