Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System— 510(k) K231438

Substantially Equivalent

Alphatec Spine, Inc.

FDA 510(k) clearance K231438 for Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System, Substantially Equivalent on 2023-07-13. Applicant: Alphatec Spine, Inc..

Clearance details

Applicant: Alphatec Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-05-17
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.