Medical Device Manufacturer · US , Beaverton , OR

Acu Med, Inc.

48 submissions · 39 cleared · Since 1990
48
Total
39
Cleared
0
Denied

Acu Med, Inc. — FDA 510(k) Submissions

Acu Med, Inc. has submitted 48 FDA 510(k) premarket notifications since 1990, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Rod, Fixation, Intramedullary And Accessories, Screw, Fixation, Bone, Plate, Fixation, Bone, Washer, Bolt Nut, Cerclage, Fixation . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
WRIST FUSION PLATE
K021321 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2002 83d
POLARUS CAP SCREW
K013616 · HSB Rod, Fixation,... · Orthopedic
Dec 2001 44d
CONGRUENT BONE PLATE SYSTEM
K012655 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2001 86d
ACUMED MODULAR SHOULDER SYSTEM
K992525 · HSD Prosthesis, Shoulder,... · Orthopedic
Feb 2000 191d
ACUMED SUTURE ANCHOR
K993657 · MBI Fastener, Fixation,... · Orthopedic
Jan 2000 77d
ACUMED SUTURE ANCHOR
K980103 · MBI Fastener, Fixation,... · Orthopedic
Mar 1998 63d
ACUMED SUTURE WASHER
K965028 · HTN Washer, Bolt Nut · Orthopedic
Mar 1997 90d
STABLELOC II EXTERNAL FIXATOR
K965029 · JEC Component, Traction,... · Orthopedic
Feb 1997 64d
ACUMED TENSION BAND PIN
K964500 · HTY Pin, Fixation, Smooth · Orthopedic
Dec 1996 31d
TBD
K963026 · HSB Rod, Fixation,... · Orthopedic
Oct 1996 84d
EXTREMITY BONE SCREW
K963118 · HWC Screw, Fixation, Bone · Orthopedic
Oct 1996 59d
TBD
K963077 · HSB Rod, Fixation,... · Orthopedic
Oct 1996 54d
POLARUS AF ROD
K962091 · HSB Rod, Fixation,... · Orthopedic
Jul 1996 56d
ACUPUNCTURE NEEDLE PACK
K960769 · MQX Needle, Acupuncture,... · General Hospital
Jul 1996 135d
ACUMED BONE GRAFT SYSTEM
K960711 · KIJ Instrument, Surgical,... · Orthopedic
May 1996 76d
CERCLAGE WIRE CRIMP BLOCK
K960651 · JDQ Cerclage, Fixation · Orthopedic
May 1996 78d
SUTURE WASHER
K954148 · HTN Washer, Bolt Nut · Orthopedic
Jan 1996 134d
EXTERNAL FIXATOR
K952330 · JEC Component, Traction,... · Orthopedic
Oct 1995 140d
INTRAMEDULARY FIXATION ROD
K951740 · HSB Rod, Fixation,... · Orthopedic
Aug 1995 140d
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
K950864 · LZJ Prosthesis, Toe... · Orthopedic
Jul 1995 154d
TENTATIVELY POLARUS EX ROD
K952534 · HSB Rod, Fixation,... · Orthopedic
Jul 1995 42d
BONE FIXATION NAIL
K943855 · JDS Nail, Fixation, Bone · Orthopedic
Jul 1995 338d
FIXATION PINS/WIRES
K943856 · HTY Pin, Fixation, Smooth · Orthopedic
Jul 1995 332d
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
K951673 · HSB Rod, Fixation,... · Orthopedic
Jul 1995 86d
ACUTRAK PLUS FIXATION SYSTEM
K944330 · HWC Screw, Fixation, Bone · Orthopedic
May 1995 241d
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