4CIS PEEK, PLIF AND TLIF CAGE SYSTEM— 510(k) K092162
Substantially EquivalentSolco Biomedical Co., Ltd.
FDA 510(k) clearance K092162 for 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM, Substantially Equivalent on 2010-01-06. Applicant: Solco Biomedical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Solco Biomedical Co., Ltd.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code MAX
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 MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.