4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM— 510(k) K102458
Substantially EquivalentSolco Biomedical Co., Ltd.
FDA 510(k) clearance K102458 for 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM, Substantially Equivalent on 2011-06-13. Applicant: Solco Biomedical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Solco Biomedical Co., Ltd.
- Product code
- Code MNH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockville, MD, US
Recent devices under product code MNH
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view all- K231655 — 4CIS® Chiron Spinal Fixation System
- K203233 — 4CIS Chiron Spinal Fixation System
- K192044 — 4CIS Marlin PEEK ACIF Cage
- 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
- K190471 — 4CIS® Chiron Spinal Fixation System
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.