Company · US
Solco Biomedical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2024. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| HRS | Plate, Fixation, Bone | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2024 | K231655 | 4CIS® Chiron Spinal Fixation System Solco Biomedical Co., Ltd., KR | NKB |
| Jun 1, 2022 | K203233 | 4CIS Chiron Spinal Fixation System Solco Biomedical Co., Ltd., KR | NKB |
| Dec 19, 2019 | K192044 | 4CIS Marlin PEEK ACIF Cage Solco Biomedical Co., Ltd., KR | ODP |
| Sep 18, 2019 | K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Solco Biomedical Co., Ltd., KR | MAX |
| Jul 24, 2019 | K190471 | 4CIS® Chiron Spinal Fixation System Solco Biomedical Co., Ltd., KR | NKB |
| Jan 16, 2019 | K182489 | 4CIS® Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd., KR | KWQ |
| Feb 16, 2017 | K162402 | 4CIS® Marlin ACIF Cage System Solco Biomedical Co., Ltd., KR | ODP |
| Aug 15, 2012 | K121615 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNI |
| Jun 13, 2011 | K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Feb 11, 2011 | K101818 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Jan 6, 2010 | K092162 | 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM Solco Biomedical Co., Ltd. | MAX |
| Nov 5, 2008 | K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNI |
| Sep 23, 2008 | K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS Solco Biomedical Co., Ltd. | MNH |
| Jun 22, 2006 | K060702 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Jul 11, 2005 | K051155 | SOLCO 4CIS GENERAL PLATE SYSTEM Solco Biomedical Co., Ltd. | HRS |
| May 12, 2005 | K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Mar 7, 2005 | K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM Solco Biomedical Co., Ltd. | MNH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||