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FDA 510(k)

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

K-Number: K991528 · 1999-05-28

ApplicantDanek Medical, Inc.
Decision Date1999-05-28
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K991528. 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 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR?

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Danek Medical, Inc.. The 510(k) number is K991528.

When did MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR receive FDA 510(k) clearance?

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR received FDA 510(k) clearance on 1999-05-28, under 510(k) number K991528.

Who is the listed applicant for MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR?

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

What is the FDA product code for MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR?

The FDA product code for MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR is MNH. This falls under the ENT category.

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Other records listing Danek Medical, Inc. as applicant

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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

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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