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FDA 510(k)

HAIDER-UCR SPINAL SYSTEM

K-Number: K993503 · 2000-04-14

ApplicantInternational Advanced Medical Enterprises, Inc.
Decision Date2000-04-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAIDER-UCR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Advanced Medical Enterprises, Inc.. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K993503. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAIDER-UCR SPINAL SYSTEM?

HAIDER-UCR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is International Advanced Medical Enterprises, Inc.. The 510(k) number is K993503.

When did HAIDER-UCR SPINAL SYSTEM receive FDA 510(k) clearance?

HAIDER-UCR SPINAL SYSTEM received FDA 510(k) clearance on 2000-04-14, under 510(k) number K993503.

Who is the listed applicant for HAIDER-UCR SPINAL SYSTEM?

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

What is the FDA product code for HAIDER-UCR SPINAL SYSTEM?

The FDA product code for HAIDER-UCR SPINAL SYSTEM is MNH. This falls under the ENT category.

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Related Devices (Code: MNH)

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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