Medical Device Manufacturer · US , Mchenry , IL

Orthopedic Systems, Inc.

95 submissions · 89 cleared · Since 1977
95
Total
89
Cleared
0
Denied

Orthopedic Systems, Inc. — FDA 510(k) Submissions

Orthopedic Systems, Inc. has submitted 95 FDA 510(k) premarket notifications since 1977, of which 89 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Operating Room Accessories Table Tray, Apparatus, Traction, Non-powered, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Arthroscope, Screw, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

95 devices
1–25 of 95
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
K952495 · LXH Orthopedic Manual... · Orthopedic
Jan 1996 237d
SPINE MOTION ANALYZER WITH EMG
K920256 · KQX Goniometer, Ac-powered · Neurology
Aug 1992 202d
JACKSON MULTIPURPOSE OPERATING TABLE
K910736 · JEA Table, Surgical With... · General & Plastic Surgery
May 1991 89d
PARK CITY SHOULDER POSITIONER
K910031 · FWZ Operating Room... · General & Plastic Surgery
Jan 1991 20d
C FIT CUP
K903938 · JDI Prosthesis, Hip,... · Orthopedic
Jan 1991 130d
NUFFIELD TOTAL KNEE
K892503 · JWH Prosthesis, Knee,... · Orthopedic
May 1990 388d
SILICONE PLUG
K896678 · HRX Arthroscope · Orthopedic
Jan 1990 64d
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · KQX Goniometer, Ac-powered · Neurology
Jan 1990 210d
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331 · LWJ Prosthesis, Hip,... · Orthopedic
Oct 1989 263d
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · JDI Prosthesis, Hip,... · Orthopedic
Oct 1989 254d
CORTICAL SCREW
K895217 · HWC Screw, Fixation, Bone · Orthopedic
Sep 1989 25d
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · HWC Screw, Fixation, Bone · Orthopedic
Sep 1989 25d
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · HWC Screw, Fixation, Bone · Orthopedic
Sep 1989 25d
UNIVERSAL CEMENTED CUP
K894249 · JDI Prosthesis, Hip,... · Orthopedic
Aug 1989 43d
CTI II STRAIGHT STEM
K891539 · LWJ Prosthesis, Hip,... · Orthopedic
Jun 1989 83d
COHN TARGETEER
K891903 · LXH Orthopedic Manual... · Orthopedic
May 1989 49d
C-S IMPACTOR
K890185 · LYP Accessories, Fixation,... · Orthopedic
Apr 1989 78d
THE C-S DISTRACTION ROD ASSEMBLY
K890187 · KWP Appliance, Fixation,... · Orthopedic
Apr 1989 78d
BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
K875130 · HRX Arthroscope · Orthopedic
Jan 1989 412d
CRUCIOMETER
K884483 · JZE Spoon, Ear · Ear, Nose, Throat
Jan 1989 85d
BOVAC SMOKE COLLECTOR
K884641 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1988 45d
ASST-3000 SPINAL SURGERY TABLE
K883457 · FWY Table, Operating-room,... · General & Plastic Surgery
Aug 1988 14d
FIXATOR PIN (EXTERNAL)
K881511 · JDW Pin, Fixation, Threaded · Orthopedic
Jun 1988 80d
CORIN MODULAR MOORE STEM
K881288 · LWJ Prosthesis, Hip,... · Orthopedic
Jun 1988 93d
CORIN BIPOLAR PROSTHESIS
K881289 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Jun 1988 93d

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