Medical Device Manufacturer · US , Bethesda , MD

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

17 submissions · 17 cleared · Since 2005
17
Total
17
Cleared
0
Denied

Solco Biomedical Co., Ltd. has 17 FDA 510(k) cleared orthopedic devices. Based in Bethesda, US.

Latest FDA clearance: Nov 2024. Active since 2005.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Solco Biomedical Co., Ltd.
17 devices
1-17 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
Cleared Sep 23, 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · MNH
Orthopedic · 29d
Cleared Jun 22, 2006
4CIS VANE SPINE SYSTEM
K060702 · MNH
Orthopedic · 98d
Cleared Jul 11, 2005
SOLCO 4CIS GENERAL PLATE SYSTEM
K051155 · HRS
Orthopedic · 68d
Cleared May 12, 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · MNH
Orthopedic · 78d
Cleared Mar 07, 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · MNH
Orthopedic · 69d
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