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FDA 510(k)

RIGIDYNE A EXTERNAL FIXATION SYSTEM

K-Number: K955780 · 1996-02-09

ApplicantZimmer, Inc.
Decision Date1996-02-09
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIGIDYNE A EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K955780. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGIDYNE A EXTERNAL FIXATION SYSTEM?

RIGIDYNE A EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K955780.

When did RIGIDYNE A EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

RIGIDYNE A EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955780.

Who is the listed applicant for RIGIDYNE A EXTERNAL FIXATION SYSTEM?

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

What is the FDA product code for RIGIDYNE A EXTERNAL FIXATION SYSTEM?

The FDA product code for RIGIDYNE A EXTERNAL FIXATION SYSTEM is JDW.

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Related Devices (Code: JDW)

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K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

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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