4CIS® Pinehurst Anterior Cervical Plate system— 510(k) K182489
Substantially EquivalentSolco Biomedical Co., Ltd.
FDA 510(k) clearance K182489 for 4CIS® Pinehurst Anterior Cervical Plate system, Substantially Equivalent on 2019-01-16. Applicant: Solco Biomedical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Solco Biomedical Co., Ltd.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek, KR
Recent devices under product code KWQ
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 KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.