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FDA 510(k)

SPINA SYSTEM

K-Number: K002260 · 2000-08-25

ApplicantNorth American Medical Corporation (Nam)
Decision Date2000-08-25
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is North American Medical Corporation (Nam). It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K002260. 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 SPINA SYSTEM?

SPINA SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is North American Medical Corporation (Nam). The 510(k) number is K002260.

When did SPINA SYSTEM receive FDA 510(k) clearance?

SPINA SYSTEM received FDA 510(k) clearance on 2000-08-25, under 510(k) number K002260.

Who is the listed applicant for SPINA SYSTEM?

The FDA 510(k) record lists North American Medical Corporation (Nam) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINA SYSTEM?

The FDA product code for SPINA SYSTEM is ITH.

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Related Devices (Code: ITH)

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

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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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