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FDA 510(k)

ORTHOFIX

K-Number: K831576 · 1983-06-08

ApplicantElectro-Biology, Inc.
Decision Date1983-06-08
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Biology, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831576. 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 ORTHOFIX?

ORTHOFIX is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K831576.

When did ORTHOFIX receive FDA 510(k) clearance?

ORTHOFIX received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831576.

Who is the listed applicant for ORTHOFIX?

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

What is the FDA product code for ORTHOFIX?

The FDA product code for ORTHOFIX is JEC.

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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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