OSTEOMED MSS— 510(k) K961418

Name: FDA 510(k) clearance K961418
Creator: U.S. Food and Drug Administration
Published: 1996-10-25

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K961418 for OSTEOMED MSS, Substantially Equivalent on 1996-10-25. Applicant: Osteomed Corp.. Device class: 2.

Clearance details

Applicant: Osteomed Corp.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 1996-04-12
Decision date: 1996-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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K233419 — GBR System2025-01-03

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K151021 — OsteoMed Cannulated Screw System2015-07-15
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K022887 — INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM2002-11-26
K022886 — METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM2002-11-25
K023260 — 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM2002-10-18

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.