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FDA 510(k)

SPINERX-LDM

K-Number: K031862 · 2003-10-31

ApplicantSpinerx Technology
Decision Date2003-10-31
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINERX-LDM is the device name listed in this FDA 510(k) record. The listed applicant is Spinerx Technology. It received FDA 510(k) clearance on 2003-10-31 under 510(k) number K031862. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINERX-LDM?

SPINERX-LDM is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Spinerx Technology. The 510(k) number is K031862.

When did SPINERX-LDM receive FDA 510(k) clearance?

SPINERX-LDM received FDA 510(k) clearance on 2003-10-31, under 510(k) number K031862.

Who is the listed applicant for SPINERX-LDM?

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

What is the FDA product code for SPINERX-LDM?

The FDA product code for SPINERX-LDM is ITH.

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Related Devices (Code: ITH)

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Official Source

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

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