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FDA 510(k)

PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS

K-Number: K071174 · 2007-07-25

ApplicantAbbott Spine, Inc.
Decision Date2007-07-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Spine, Inc.. It received FDA 510(k) clearance on 2007-07-25 under 510(k) number K071174. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS?

PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS is a medical device that received FDA 510(k) clearance on 2007-07-25. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K071174.

When did PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS receive FDA 510(k) clearance?

PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS received FDA 510(k) clearance on 2007-07-25, under 510(k) number K071174.

Who is the listed applicant for PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS?

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

What is the FDA product code for PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS?

The FDA product code for PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS is NKB.

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Other records listing Abbott Spine, Inc. as applicant

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K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIESK082032SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)K081622UNIVERSAL CLAMP STAINLESS STEEL SYSTEMK073202ARDIS SPACERK072672SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIESK062505NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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