Solco Biomedical Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Solco Biomedical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: 4CIS® Chiron Spinal Fixation System, 4CIS Chiron Spinal Fixation System, 4CIS Marlin PEEK ACIF Cage
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.
510(k) submissions have been managed by First Gold Corp. as regulatory consultant.
FDA 510(k) Regulatory Record - Solco Biomedical Co., Ltd.
17 devices
Cleared
Nov 26, 2024
4CIS® Chiron Spinal Fixation System
Orthopedic
539d
Cleared
Jun 01, 2022
4CIS Chiron Spinal Fixation System
Orthopedic
576d
Cleared
Dec 19, 2019
4CIS Marlin PEEK ACIF Cage
Orthopedic
141d
Cleared
Sep 18, 2019
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK...
Orthopedic
197d
Cleared
Jul 24, 2019
4CIS® Chiron Spinal Fixation System
Orthopedic
148d
Cleared
Jan 16, 2019
4CIS® Pinehurst Anterior Cervical Plate system
Orthopedic
127d
Cleared
Feb 16, 2017
4CIS® Marlin ACIF Cage System
Orthopedic
174d
Cleared
Aug 15, 2012
4CIS VANE SPINE SYSTEM
Orthopedic
75d
Cleared
Jun 13, 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
Orthopedic
290d
Cleared
Feb 11, 2011
4CIS VANE SPINE SYSTEM
Orthopedic
226d
Cleared
Jan 06, 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
Orthopedic
174d
Cleared
Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
Orthopedic
197d