SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM— 510(k) K042508

Name: FDA 510(k) clearance K042508
Creator: U.S. Food and Drug Administration
Published: 2004-10-07

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K042508 for SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: Depuy Spine, Inc.. Device class: 2.

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2004-09-15
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, 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 Depuy Spine, Inc.

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K201831 — CONFIDENCE Spinal Cement System2020-08-31
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K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM2012-06-14
K121020 — VIPER SYSTEM2012-05-03
K110353 — MOUNTAINEER OCT SPINAL SYSTEM2011-04-07

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.