Bone Screw, Bone Tack— 510(k) K182881

Name: FDA 510(k) clearance K182881
Creator: U.S. Food and Drug Administration
Published: 2019-08-09

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K182881 for Bone Screw, Bone Tack, Substantially Equivalent on 2019-08-09. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2018-10-15
Decision date: 2019-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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K251569 — Bone Screw2025-08-13
K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN2025-06-27
K233419 — GBR System2025-01-03

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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.