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FDA 510(k)

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

K-Number: K944092 · 1995-04-04

ApplicantOrthofix Srl
Decision Date1995-04-04
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 1995-04-04 under 510(k) number K944092. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM?

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-04. The listed applicant is Orthofix Srl. The 510(k) number is K944092.

When did ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM receive FDA 510(k) clearance?

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM received FDA 510(k) clearance on 1995-04-04, under 510(k) number K944092.

Who is the listed applicant for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM?

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

What is the FDA product code for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM?

The FDA product code for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM is JEC.

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Other records listing Orthofix Srl as applicant

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Related Devices (Code: JEC)

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K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, 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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