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FDA 510(k)

ENTRAX TRACTION UNIT

K-Number: K780763 · 1978-05-16

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1978-05-16
Product CodeHSR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENTRAX TRACTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1978-05-16 under 510(k) number K780763. The device is classified under product code HSR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTRAX TRACTION UNIT?

ENTRAX TRACTION UNIT is a medical device that received FDA 510(k) clearance on 1978-05-16. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K780763.

When did ENTRAX TRACTION UNIT receive FDA 510(k) clearance?

ENTRAX TRACTION UNIT received FDA 510(k) clearance on 1978-05-16, under 510(k) number K780763.

Who is the listed applicant for ENTRAX TRACTION UNIT?

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

What is the FDA product code for ENTRAX TRACTION UNIT?

The FDA product code for ENTRAX TRACTION UNIT is HSR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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