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FDA 510(k)

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM

K-Number: K103262 · 2011-04-05

ApplicantTornier, Inc.
Decision Date2011-04-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K103262. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM?

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Tornier, Inc.. The 510(k) number is K103262.

When did QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM receive FDA 510(k) clearance?

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM received FDA 510(k) clearance on 2011-04-05, under 510(k) number K103262.

Who is the listed applicant for QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM?

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

What is the FDA product code for QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM?

The FDA product code for QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM is MBI.

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Other records listing Tornier, Inc. as applicant

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Related Devices (Code: MBI)

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.

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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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