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FDA 510(k)

Premilled Titanium Block System

K-Number: K203344 · 2021-08-25

ApplicantInnobiosurg Co., Ltd.
Decision Date2021-08-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premilled Titanium Block System is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2021-08-25 under approval number K203344. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Premilled Titanium Block System?

Premilled Titanium Block System is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K203344.

When was Premilled Titanium Block System approved by the FDA?

Premilled Titanium Block System received FDA 510(k) clearance on 2021-08-25, under approval number K203344.

What company makes Premilled Titanium Block System?

Premilled Titanium Block System is manufactured by Innobiosurg Co., Ltd..

What is the FDA product code for Premilled Titanium Block System?

The FDA product code for Premilled Titanium Block System is NHA.

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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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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