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FDA 510(k)

UNIVERSAL CLAMP STAINLESS STEEL SYSTEM

K-Number: K081622 · 2008-08-29

ApplicantAbbott Spine, Inc.
Decision Date2008-08-29
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CLAMP STAINLESS STEEL 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 2008-08-29 under 510(k) number K081622. 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 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM?

UNIVERSAL CLAMP STAINLESS STEEL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K081622.

When did UNIVERSAL CLAMP STAINLESS STEEL SYSTEM receive FDA 510(k) clearance?

UNIVERSAL CLAMP STAINLESS STEEL SYSTEM received FDA 510(k) clearance on 2008-08-29, under 510(k) number K081622.

Who is the listed applicant for UNIVERSAL CLAMP STAINLESS STEEL 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 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM?

The FDA product code for UNIVERSAL CLAMP STAINLESS STEEL SYSTEM is JDQ.

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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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