ISOBAR SPINAL SYSTEM— 510(k) K990118

Name: FDA 510(k) clearance K990118
Creator: U.S. Food and Drug Administration
Published: 1999-03-22

Substantially Equivalent

Scien'Tx USA, Inc.

FDA 510(k) clearance K990118 for ISOBAR SPINAL SYSTEM, Substantially Equivalent on 1999-03-22. Applicant: Scien'Tx USA, Inc.. Device class: 2.

Clearance details

Applicant: Scien'Tx USA, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1999-01-13
Decision date: 1999-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Scien'Tx USA, Inc.

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K020245 — MODIFICATION TO ISOBAR SPINAL SYSTEM2002-02-01
K013447 — ISOBAR SPINAL SYSTEM2002-01-15
K013439 — ANTERIOR CERVICAL PLATE SYSTEM2002-01-14
K013440 — ISOBAR SPINAL SYSTEM2001-11-16
K013444 — ISOBAR SPINAL SYSTEM2001-11-16

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.