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FDA 510(k)

NEXLINK OCT SYSTEM, MODEL 7000 SERIES

K-Number: K090060 · 2009-06-02

ApplicantAbbott Spine, Inc.
Decision Date2009-06-02
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXLINK OCT SYSTEM, MODEL 7000 SERIES 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 2009-06-02 under 510(k) number K090060. 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 NEXLINK OCT SYSTEM, MODEL 7000 SERIES?

NEXLINK OCT SYSTEM, MODEL 7000 SERIES is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K090060.

When did NEXLINK OCT SYSTEM, MODEL 7000 SERIES receive FDA 510(k) clearance?

NEXLINK OCT SYSTEM, MODEL 7000 SERIES received FDA 510(k) clearance on 2009-06-02, under 510(k) number K090060.

Who is the listed applicant for NEXLINK OCT SYSTEM, MODEL 7000 SERIES?

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 NEXLINK OCT SYSTEM, MODEL 7000 SERIES?

The FDA product code for NEXLINK OCT SYSTEM, MODEL 7000 SERIES is KWP.

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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.

K082032SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)K081622UNIVERSAL 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: 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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