7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array— 510(k) K201966

Substantially Equivalent

7D Surgical, Inc.

FDA 510(k) clearance K201966 for 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array, Substantially Equivalent on 2020-09-03. Applicant: 7D Surgical, Inc..

Clearance details

Applicant: 7D Surgical, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2020-07-15
Decision date: 2020-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.