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FDA 510(k)

HUMEROUS FRACTURE BRACE, ULNA FRACTURE

K-Number: K801788 · 1980-08-07

ApplicantHosmer Dorrance Corp.
Decision Date1980-08-07
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUMEROUS FRACTURE BRACE, ULNA FRACTURE is the device name listed in this FDA 510(k) record. The listed applicant is Hosmer Dorrance Corp.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801788. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMEROUS FRACTURE BRACE, ULNA FRACTURE?

HUMEROUS FRACTURE BRACE, ULNA FRACTURE is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Hosmer Dorrance Corp.. The 510(k) number is K801788.

When did HUMEROUS FRACTURE BRACE, ULNA FRACTURE receive FDA 510(k) clearance?

HUMEROUS FRACTURE BRACE, ULNA FRACTURE received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801788.

Who is the listed applicant for HUMEROUS FRACTURE BRACE, ULNA FRACTURE?

The FDA 510(k) record lists Hosmer Dorrance Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMEROUS FRACTURE BRACE, ULNA FRACTURE?

The FDA product code for HUMEROUS FRACTURE BRACE, ULNA FRACTURE is IQI.

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Other records listing Hosmer Dorrance Corp. 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.

K822632ELBOW PROSTHESISK821704FRACTURE BRACINGK780890CAPP TERMINAL DEVICEK780892FRACTURE BRACINGK780891POST-OPERATIVE HIP ORTHOSISK761312ORTHOTIC BRACING

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Related Devices (Code: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred 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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