LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S— 510(k) K121103

Substantially Equivalent

Ldr Spine USA, Inc.

FDA 510(k) clearance K121103 for LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S, Substantially Equivalent on 2012-08-24. Applicant: Ldr Spine USA, Inc..

Clearance details

Applicant: Ldr Spine USA, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2012-04-11
Decision date: 2012-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.