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FDA 510(k)

OPTIMESH

K-Number: K014200 · 2003-11-26

ApplicantSpineology, Inc.
Decision Date2003-11-26
Product CodeEZX
Advisory CommitteeSU
DecisionUnknown

Device Summary

OPTIMESH is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K014200. The device is classified under product code EZX. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the OPTIMESH?

OPTIMESH is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Spineology, Inc.. The 510(k) number is K014200.

When did OPTIMESH receive FDA 510(k) clearance?

OPTIMESH received FDA 510(k) clearance on 2003-11-26, under 510(k) number K014200.

Who is the listed applicant for OPTIMESH?

The FDA 510(k) record lists Spineology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMESH?

The FDA product code for OPTIMESH is EZX.

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Other records listing Spineology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemK251943Spineology Navigation InstrumentsK230927OptiMesh Multiplanar Expandable Interbody Fusion SystemK231781OptiMesh Multiplanar Expandable Interbody Fusion SystemK213876Spineology Navigation InstrumentsK210155Duo Expandable Interbody Fusion System

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Related Devices (Code: EZX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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