Medical Device Manufacturer · US , Bethesda , MD

Solco Biomedical Co., Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2005

Recent clearances: 4CIS® Chiron Spinal Fixation System, 4CIS Chiron Spinal Fixation System, 4CIS Marlin PEEK ACIF Cage

17
Total
17
Cleared
0
Denied

FDA 510(k) Regulatory Record - Solco Biomedical Co., Ltd. Orthopedic ✕

17 devices
1-12 of 17
Cleared Nov 26, 2024
4CIS® Chiron Spinal Fixation System
K231655 · NKB
Orthopedic · 539d
Cleared Jun 01, 2022
4CIS Chiron Spinal Fixation System
K203233 · NKB
Orthopedic · 576d
Cleared Dec 19, 2019
4CIS Marlin PEEK ACIF Cage
K192044 · ODP
Orthopedic · 141d
Cleared Sep 18, 2019
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK...
K190563 · MAX
Orthopedic · 197d
Cleared Jul 24, 2019
4CIS® Chiron Spinal Fixation System
K190471 · NKB
Orthopedic · 148d
Cleared Jan 16, 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · KWQ
Orthopedic · 127d
Cleared Feb 16, 2017
4CIS® Marlin ACIF Cage System
K162402 · ODP
Orthopedic · 174d
Cleared Aug 15, 2012
4CIS VANE SPINE SYSTEM
K121615 · MNI
Orthopedic · 75d
Cleared Jun 13, 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · MNH
Orthopedic · 290d
Cleared Feb 11, 2011
4CIS VANE SPINE SYSTEM
K101818 · MNH
Orthopedic · 226d
Cleared Jan 06, 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K092162 · MAX
Orthopedic · 174d
Cleared Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145 · MNI
Orthopedic · 197d
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