LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM— 510(k) K070341

Name: FDA 510(k) clearance K070341
Creator: U.S. Food and Drug Administration
Published: 2007-08-08

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K070341 for LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM, Substantially Equivalent on 2007-08-08. Applicant: Ldr Spine USA. Device class: 2.

Clearance details

Applicant: Ldr Spine USA
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2007-02-06
Decision date: 2007-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from Ldr Spine USA

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K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System2016-03-31
K152137 — FacetBRIDGE System2016-01-25
K151934 — ROI-C Titanium-Coated Implant System2015-12-07
K150765 — LDR Spine ROI-C Cervical Cage System2015-09-17
K110327 — LDR SPINE ROI-A INTERBODY FUSION SYSTEM2011-09-30

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.