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FDA 510(k)

MODIFICATION TO DYNESYS SPINAL SYSTEM

K-Number: K043565 · 2005-03-11

ApplicantZimmer Spine, Inc.
Decision Date2005-03-11
Product CodeNQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DYNESYS SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2005-03-11 under 510(k) number K043565. The device is classified under product code NQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO DYNESYS SPINAL SYSTEM?

MODIFICATION TO DYNESYS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-11. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K043565.

When did MODIFICATION TO DYNESYS SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO DYNESYS SPINAL SYSTEM received FDA 510(k) clearance on 2005-03-11, under 510(k) number K043565.

Who is the listed applicant for MODIFICATION TO DYNESYS SPINAL SYSTEM?

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

What is the FDA product code for MODIFICATION TO DYNESYS SPINAL SYSTEM?

The FDA product code for MODIFICATION TO DYNESYS SPINAL SYSTEM is NQP.

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Other records listing Zimmer Spine, Inc. as applicant

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K153631Zimmer Virage OCT Spinal Fixation SystemK132790INFIX ANTERIOR LUMBAR SYSTEMK133291ST360 DEGREES SPINAL FIXATION SYSTEMK133086TITLE 2 POLYAXIAL SPINAL SYSTEMK132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMK131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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Related Devices (Code: NQP)

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.

K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K101704ZIMMER DTO PIN PRESS INSTRUMENTZimmer Spine, Inc.K101083DSS STABILIZATION SYSTEMParadigm Spine, LLCK092234DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.

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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