ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03— 510(k) K031452

Name: FDA 510(k) clearance K031452
Creator: U.S. Food and Drug Administration
Published: 2003-06-18

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K031452 for ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03, Substantially Equivalent on 2003-06-18. Applicant: Ortho Tec, LLC. Device class: 2.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2003-05-07
Decision date: 2003-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: California, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho Tec, LLC

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K040514 — EOVIA CALCIUM PHOSPHATE CERAMIC2004-05-03
K040346 — MODIFICATION TO ORIA TOP CLIP SYSTEM2004-03-12
K030958 — ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS2003-11-20
K031471 — ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL012003-10-10
K023884 — MODIFICATION ORIA SPINAL SYSTEM2003-08-20

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.