Medical Device Manufacturer · US , Mchenry , IL

Acufex Microsurgical, Inc.

78 submissions · 75 cleared · Since 1980
78
Total
75
Cleared
0
Denied

Acufex Microsurgical, Inc. — FDA 510(k) Submissions

Acufex Microsurgical, Inc. has submitted 78 FDA 510(k) premarket notifications since 1980, of which 75 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Arthroscope, Staple, Fixation, Bone, Screw, Fixation, Bone, Retention Device, Suture, Laparoscope, General & Plastic Surgery . Use the specialty filter in the sidebar to narrow results.

78 devices
1–12 of 78
ACUFEX TAG BIOABSORBABLE ANCHORS
K961555 · JDR Staple, Fixation, Bone · Orthopedic
Jul 1996 79d
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
K961853 · HRX Arthroscope · General & Plastic Surgery
Jun 1996 38d
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · HWC Screw, Fixation, Bone · Orthopedic
Feb 1996 157d
ACUFEX ENDOBUTTON TAPE
K952535 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Feb 1996 252d
ACUFEX TAG DELIVERY SYSTEM
K953276 · JDR Staple, Fixation, Bone · Orthopedic
Oct 1995 83d
ACUFEX TAG ANCHOR
K953459 · MBI Fastener, Fixation,... · Orthopedic
Aug 1995 30d
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · KGS Retention Device, Suture · General & Plastic Surgery
Jun 1995 449d
ACUFEX PATELLAR BONE BLOCK SIZER
K944500 · HRX Arthroscope · Orthopedic
Jun 1995 271d
ACUFEX ENDOBUTTON PACK
K951859 · HRX Arthroscope · Orthopedic
Jun 1995 49d
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · JDR Staple, Fixation, Bone · Orthopedic
Apr 1995 117d
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · HRX Arthroscope · Orthopedic
Apr 1995 373d
BIOABSORBABLE INTERFERENCE SCREW
K943548 · JDR Staple, Fixation, Bone · Orthopedic
Mar 1995 242d

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