ISSYS LP SPINAL FIXATION SYSTEM— 510(k) K111099

Substantially Equivalent

Custom Spine, Inc.

FDA 510(k) clearance K111099 for ISSYS LP SPINAL FIXATION SYSTEM, Substantially Equivalent on 2011-05-05. Applicant: Custom Spine, Inc..

Clearance details

Applicant: Custom Spine, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2011-04-20
Decision date: 2011-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, 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.