Medical Device Manufacturer · US , Marina Del Rey , CA

Karlin Technology, Inc.

17 submissions · 17 cleared · Since 1988
17
Total
17
Cleared
0
Denied

Karlin Technology, Inc. — FDA 510(k) Submissions

Karlin Technology, Inc. has submitted 17 FDA 510(k) premarket notifications since 1988, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Retractor, Appliance, Fixation, Spinal Interlaminal, Orthopedic Manual Surgical Instrument, Board, Arm (with Cover), Sterile, Knife, Orthopedic . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · GAD Retractor · General & Plastic Surgery
Sep 1990 8d
BONE PLATE
K893201 · HRS Plate, Fixation, Bone · Orthopedic
Apr 1990 343d
BONE SCREW
K893203 · JDR Staple, Fixation, Bone · Orthopedic
Apr 1990 343d
SPINAL MICROKNIFE
K882525 · HTS Knife, Orthopedic · Orthopedic
Sep 1988 97d
X-RAY MARKER
K882519 · JAC System, X-ray, Film... · Radiology
Aug 1988 53d
SPINAL NEEDLE
K882073 · GDM Needle, Aspiration And... · General & Plastic Surgery
Jul 1988 62d
SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS
K882520 · LWG Surgical Table Cushion · General & Plastic Surgery
Jul 1988 31d
UNIVERSALLY ADJUSTABLE ARMBOARD
K882524 · BTX Board, Arm (with Cover),... · General & Plastic Surgery
Jul 1988 21d
SPINAL DISTRACTORS, SPANNERS
K882069 · LXH Orthopedic Manual... · Orthopedic
Jun 1988 31d
ORTHOPAEDIC AND SPINAL RING CURRETTES
K882072 · JXH Methyl Methacrylate For... · Neurology
Jun 1988 31d
MICRODISCECTOMY CURRETTES
K882077 · LXH Orthopedic Manual... · Orthopedic
Jun 1988 31d
SUCTION RETRACTORS
K882074 · GAD Retractor · General & Plastic Surgery
Jun 1988 30d
SELF-RETAINING SOFT TISSUE RETRACTOR
K882075 · GAD Retractor · General & Plastic Surgery
Jun 1988 30d
SPINAL SURGERY FRAME
K882078 · FWZ Operating Room... · General & Plastic Surgery
Jun 1988 30d
CRANK FRAME RETRACTOR
K882071 · GZT Retractor,... · Neurology
Jun 1988 24d
COBB SPINAL ELEVATORS
K882068 · KWP Appliance, Fixation,... · Orthopedic
Jun 1988 17d
LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS
K882070 · KWP Appliance, Fixation,... · Orthopedic
Jun 1988 17d
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