GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System— 510(k) K163096

Substantially Equivalent

Gpc Medical Limited

FDA 510(k) clearance K163096 for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System, Substantially Equivalent on 2017-03-31. Applicant: Gpc Medical Limited.

Clearance details

Applicant: Gpc Medical Limited
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2016-11-04
Decision date: 2017-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Delhi, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.