Matrix HA PEEK Cervical Implant System— 510(k) K192316

Substantially Equivalent

Sapphire Medical Group

FDA 510(k) clearance K192316 for Matrix HA PEEK Cervical Implant System, Substantially Equivalent on 2019-10-17. Applicant: Sapphire Medical Group.

Clearance details

Applicant: Sapphire Medical Group
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-08-26
Decision date: 2019-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Dana Point, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.