IST PEDICLE SCREW SYSTEM— 510(k) K053276

Substantially Equivalent

Innovative Spinal Technologies, Inc.

FDA 510(k) clearance K053276 for IST PEDICLE SCREW SYSTEM, Substantially Equivalent on 2005-12-27. Applicant: Innovative Spinal Technologies, Inc..

Clearance details

Applicant: Innovative Spinal Technologies, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2005-11-23
Decision date: 2005-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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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.