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FDA 510(k)

ST360 SPINAL FIXATION SYSTEM

K-Number: K041925 · 2004-09-24

ApplicantZimmer Spine, Inc.
Decision Date2004-09-24
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ST360 SPINAL FIXATION 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 2004-09-24 under 510(k) number K041925. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST360 SPINAL FIXATION SYSTEM?

ST360 SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K041925.

When did ST360 SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

ST360 SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-09-24, under 510(k) number K041925.

Who is the listed applicant for ST360 SPINAL FIXATION 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 ST360 SPINAL FIXATION SYSTEM?

The FDA product code for ST360 SPINAL FIXATION SYSTEM is KWP.

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Other records listing Zimmer Spine, Inc. as applicant

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.

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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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