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FDA 510(k)

MALIBU SPINAL SYSTEM

K-Number: K051942 · 2005-07-27

ApplicantSeaspine, Inc.
Decision Date2005-07-27
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALIBU SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K051942. 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 MALIBU SPINAL SYSTEM?

MALIBU SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Seaspine, Inc.. The 510(k) number is K051942.

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

MALIBU SPINAL SYSTEM received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051942.

Who is the listed applicant for MALIBU SPINAL SYSTEM?

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

What is the FDA product code for MALIBU SPINAL SYSTEM?

The FDA product code for MALIBU SPINAL SYSTEM is KWP.

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Other records listing Seaspine, 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.

K231654NorthStar OCT SystemK132859INTEGRA FACET FIXATION SYSTEMK121924INTEGRA INTERSPINOUS PROCESS SYSTEMK130830INTEGRA LAMINOPLASTY SYSTEMK122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMK112206CARDIFF ANTERIOR CERVICAL PLATE 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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