FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K Number: K050471
·
Decision May 12, 2005
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
17
Review Days
78
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Basic Information
- Device Name
- 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
- K Number
- K050471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solco Biomedical Co., Ltd.
- Date Received
- February 23, 2005
- Decision Date
- May 12, 2005
- Product Code
- MNH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Solco Biomedical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation System | Nov 26, 2024 | Substantially Equivalent |
| K203233 | 4CIS Chiron Spinal Fixation System | Jun 1, 2022 | Substantially Equivalent |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Dec 19, 2019 | Substantially Equivalent |
| K190563 | 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 | Sep 18, 2019 | Substantially Equivalent |
| K190471 | 4CIS® Chiron Spinal Fixation System | Jul 24, 2019 | Substantially Equivalent |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Jan 16, 2019 | Substantially Equivalent |
| K162402 | 4CIS® Marlin ACIF Cage System | Feb 16, 2017 | Substantially Equivalent |
| K121615 | 4CIS VANE SPINE SYSTEM | Aug 15, 2012 | Substantially Equivalent |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Jun 13, 2011 | Substantially Equivalent |
| K101818 | 4CIS VANE SPINE SYSTEM | Feb 11, 2011 | Substantially Equivalent |