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510(k) Data Aggregation
K Number
K243190Device Name
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
Manufacturer
Ustomed Instrumente Ulrich Storz GmbH & Co. KG
Date Cleared
2025-06-27
(270 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
**Ustomed Instrumente Ulrich Storz GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.
Device Description
USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently.
The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.
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