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FDA 510(k)

TRUNCAL ORTHOSIS

K-Number: K810450 · 1981-03-04

ApplicantFred Sammons, Inc.
Decision Date1981-03-04
Product CodeIQE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRUNCAL ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810450. The device is classified under product code IQE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUNCAL ORTHOSIS?

TRUNCAL ORTHOSIS is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K810450.

When did TRUNCAL ORTHOSIS receive FDA 510(k) clearance?

TRUNCAL ORTHOSIS received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810450.

Who is the listed applicant for TRUNCAL ORTHOSIS?

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

What is the FDA product code for TRUNCAL ORTHOSIS?

The FDA product code for TRUNCAL ORTHOSIS is IQE.

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Other records listing Fred Sammons, Inc. as applicant

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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Related Devices (Code: IQE)

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.

K821682TRUNCAL ORTHOSISSurgical Appliance Industries, Inc.K820051OBUS FORME ORTHOPEDIC BRACE, UPRIGHTObus Forme, Ltd.K812719PROSANA BELTBandwagon, 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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