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FDA 510(k)

ORTHOFIX MODULSYSTEM

K-Number: K955848 · 1996-03-20

ApplicantOrthofix, Inc.
Decision Date1996-03-20
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX MODULSYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K955848. 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 ORTHOFIX MODULSYSTEM?

ORTHOFIX MODULSYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Orthofix, Inc.. The 510(k) number is K955848.

When did ORTHOFIX MODULSYSTEM receive FDA 510(k) clearance?

ORTHOFIX MODULSYSTEM received FDA 510(k) clearance on 1996-03-20, under 510(k) number K955848.

Who is the listed applicant for ORTHOFIX MODULSYSTEM?

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

What is the FDA product code for ORTHOFIX MODULSYSTEM?

The FDA product code for ORTHOFIX MODULSYSTEM is JDW.

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Related Devices (Code: JDW)

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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