FDA 510(k) Applications Submitted by Solco Biomedical Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203233 |
11/02/2020 |
4CIS Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
| K192044 |
07/31/2019 |
4CIS Marlin PEEK ACIF Cage |
Solco Biomedical Co., Ltd. |
| K190563 |
03/05/2019 |
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage |
Solco Biomedical Co., Ltd. |
| K182489 |
09/11/2018 |
4CIS« Pinehurst Anterior Cervical Plate system |
Solco Biomedical Co., Ltd. |
| K190471 |
02/26/2019 |
4CIS« Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
| K162402 |
08/26/2016 |
4CIS« Marlin ACIF Cage System |
SOLCO BIOMEDICAL CO., LTD. |
| K050471 |
02/23/2005 |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K060702 |
03/16/2006 |
4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K081145 |
04/22/2008 |
MODIFICATION TO 4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K051155 |
05/04/2005 |
SOLCO 4CIS GENERAL PLATE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K121615 |
06/01/2012 |
4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K101818 |
06/30/2010 |
4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K092162 |
07/16/2009 |
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K082453 |
08/25/2008 |
4CIS SOLAR AND APOLLON SPINE SYSTEMS |
SOLCO BIOMEDICAL CO., LTD. |
| K102458 |
08/27/2010 |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
| K043578 |
12/28/2004 |
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
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