Solco Biomedical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K231655 | 4CIS® Chiron Spinal Fixation System | November 26, 2024 |
| K203233 | 4CIS Chiron Spinal Fixation System | June 1, 2022 |
| K192044 | 4CIS Marlin PEEK ACIF Cage | December 19, 2019 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes | September 18, 2019 |
| K190471 | 4CIS® Chiron Spinal Fixation System | July 24, 2019 |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | January 16, 2019 |
| K162402 | 4CIS® Marlin ACIF Cage System | February 16, 2017 |
| K121615 | 4CIS VANE SPINE SYSTEM | August 15, 2012 |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | June 13, 2011 |
| K101818 | 4CIS VANE SPINE SYSTEM | February 11, 2011 |
| K092162 | 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM | January 6, 2010 |
| K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM | November 5, 2008 |
| K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS | September 23, 2008 |
| K060702 | 4CIS VANE SPINE SYSTEM | June 22, 2006 |
| K051155 | SOLCO 4CIS GENERAL PLATE SYSTEM | July 11, 2005 |
| K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | May 12, 2005 |
| K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM | March 7, 2005 |