CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM— 510(k) K131538

Substantially Equivalent

Captiva Spine

FDA 510(k) clearance K131538 for CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM, Substantially Equivalent on 2013-08-08. Applicant: Captiva Spine.

Clearance details

Applicant: Captiva Spine
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2013-05-29
Decision date: 2013-08-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Apple Valley, MN, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.