Depuy Mitek, A Johnson & Johnson Company - FDA 510(k) Cleared Devices
Recent clearances: Milagro / Milagro Advance Interference Screw, 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,, VAPR ARCTIC SUCTION ELECTRODE
58
Total
58
Cleared
0
Denied
FDA 510(k) Regulatory Record - Depuy Mitek, A Johnson & Johnson Company Orthopedic ✕
49 devices
Cleared
May 21, 2015
Milagro / Milagro Advance Interference Screw
Orthopedic
149d
Cleared
Oct 24, 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm...
Orthopedic
42d
Cleared
Jun 10, 2014
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON...
Orthopedic
26d
Cleared
Feb 04, 2014
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE,...
Orthopedic
53d
Cleared
Nov 05, 2013
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT...
Orthopedic
110d
Cleared
Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM,...
Orthopedic
129d
Cleared
Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
Orthopedic
27d
Cleared
Jul 22, 2013
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL...
Orthopedic
87d
Cleared
Jun 14, 2013
OMNICUT RESECTION BLADE
Orthopedic
73d
Cleared
May 24, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR
Orthopedic
51d
Cleared
May 21, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
Orthopedic
81d
Cleared
May 17, 2013
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS...
Orthopedic
122d
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