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FDA 510(k)

ABBOTT SPINE UNIVERSAL CLAMP SYSTEM

K-Number: K060009 · 2006-03-06

ApplicantAbbott Spine, Inc.
Decision Date2006-03-06
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABBOTT SPINE UNIVERSAL CLAMP SYSTEM 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 2006-03-06 under 510(k) number K060009. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT SPINE UNIVERSAL CLAMP SYSTEM?

ABBOTT SPINE UNIVERSAL CLAMP SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-06. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K060009.

When did ABBOTT SPINE UNIVERSAL CLAMP SYSTEM receive FDA 510(k) clearance?

ABBOTT SPINE UNIVERSAL CLAMP SYSTEM received FDA 510(k) clearance on 2006-03-06, under 510(k) number K060009.

Who is the listed applicant for ABBOTT SPINE UNIVERSAL CLAMP SYSTEM?

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 ABBOTT SPINE UNIVERSAL CLAMP SYSTEM?

The FDA product code for ABBOTT SPINE UNIVERSAL CLAMP SYSTEM is JDQ.

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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 SERIESK082032SEQUOIA 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 SCREWS

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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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