SOLCO 4CIS GENERAL PLATE SYSTEM— 510(k) K051155
Substantially EquivalentSolco Biomedical Co., Ltd.
FDA 510(k) clearance K051155 for SOLCO 4CIS GENERAL PLATE SYSTEM, Substantially Equivalent on 2005-07-11. Applicant: Solco Biomedical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Solco Biomedical Co., Ltd.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Recent devices under product code HRS
view allMore clearances from Solco Biomedical Co., Ltd.
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 HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.