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FDA 510(k)

TRUNCAL ORTHOSIS

K-Number: K821682 · 1982-06-24

ApplicantSurgical Appliance Industries, Inc.
Decision Date1982-06-24
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 Surgical Appliance Industries, Inc.. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821682. 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 1982-06-24. The listed applicant is Surgical Appliance Industries, Inc.. The 510(k) number is K821682.

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

TRUNCAL ORTHOSIS received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821682.

Who is the listed applicant for TRUNCAL ORTHOSIS?

The FDA 510(k) record lists Surgical Appliance Industries, 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 Surgical Appliance Industries, 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.

K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETK813416EXTERNAL BREAST PROSTHESISK812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. OK812423NEOPRENE KNEE SUPPORTK812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISK811689CYLINDER KNEE CAST/SPLINT

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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.

K820051OBUS FORME ORTHOPEDIC BRACE, UPRIGHTObus Forme, Ltd.K812719PROSANA BELTBandwagon, Inc.K810450TRUNCAL ORTHOSISFred Sammons, 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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