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FDA 510(k)

SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)

K-Number: K082032 · 2008-10-06

ApplicantAbbott Spine, Inc.
Decision Date2008-10-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) 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 2008-10-06 under 510(k) number K082032. 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 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)?

SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K082032.

When did SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) receive FDA 510(k) clearance?

SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) received FDA 510(k) clearance on 2008-10-06, under 510(k) number K082032.

Who is the listed applicant for SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)?

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 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)?

The FDA product code for SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) is NKB.

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Other records listing Abbott 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.

K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIESK081622UNIVERSAL CLAMP STAINLESS STEEL SYSTEMK073202ARDIS SPACERK072672SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIESK071174PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWSK062505NEX-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.OK253943Tiger 2 SystemZavation Medical Products, LLC

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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