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FDA 510(k)

USTOMED Bone Fixation/Bone Augmentation Systems - PIN

K-Number: K243190 · 2025-06-27

ApplicantUstomed Instrumente Ulrich Storz GmbH & Co. KG
Decision Date2025-06-27
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

USTOMED Bone Fixation/Bone Augmentation Systems - PIN is a medical device manufactured by Ustomed Instrumente Ulrich Storz GmbH & Co. KG. It received FDA 510(k) clearance on 2025-06-27 under approval number K243190. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USTOMED Bone Fixation/Bone Augmentation Systems - PIN?

USTOMED Bone Fixation/Bone Augmentation Systems - PIN is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Ustomed Instrumente Ulrich Storz GmbH & Co. KG. The 510(k) number is K243190.

When was USTOMED Bone Fixation/Bone Augmentation Systems - PIN approved by the FDA?

USTOMED Bone Fixation/Bone Augmentation Systems - PIN received FDA 510(k) clearance on 2025-06-27, under approval number K243190.

What company makes USTOMED Bone Fixation/Bone Augmentation Systems - PIN?

USTOMED Bone Fixation/Bone Augmentation Systems - PIN is manufactured by Ustomed Instrumente Ulrich Storz GmbH & Co. KG.

What is the FDA product code for USTOMED Bone Fixation/Bone Augmentation Systems - PIN?

The FDA product code for USTOMED Bone Fixation/Bone Augmentation Systems - PIN is DZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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