Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Solco Biomedical with 17 510(k) clearances. The most recent is a 510(k) clearance dated Nov 26, 2024: 4CIS® Chiron Spinal Fixation System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 26, 2024 | 4CIS® Chiron Spinal Fixation SystemK231655 · NKB | 510(k) clearances |
| Jun 1, 2022 | 4CIS Chiron Spinal Fixation SystemK203233 · NKB | 510(k) clearances |
| Dec 19, 2019 | 4CIS Marlin PEEK ACIF CageK192044 · ODP | 510(k) clearances |
| Sep 18, 2019 | 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 CageK190563 · MAX | 510(k) clearances |
| Jul 24, 2019 | 4CIS® Chiron Spinal Fixation SystemK190471 · NKB | 510(k) clearances |
| Jan 16, 2019 | 4CIS® Pinehurst Anterior Cervical Plate systemK182489 · KWQ | 510(k) clearances |
| Feb 16, 2017 | 4CIS® Marlin ACIF Cage SystemK162402 · ODP | 510(k) clearances |
| Aug 15, 2012 | 4CIS VANE SPINE SYSTEMK121615 · MNI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
