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FDA 510(k)

ELBOW PROSTHESIS

K-Number: K822632 · 1982-09-14

ApplicantHosmer Dorrance Corp.
Decision Date1982-09-14
Product CodeIRE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELBOW PROSTHESIS 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 1982-09-14 under 510(k) number K822632. The device is classified under product code IRE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELBOW PROSTHESIS?

ELBOW PROSTHESIS is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Hosmer Dorrance Corp.. The 510(k) number is K822632.

When did ELBOW PROSTHESIS receive FDA 510(k) clearance?

ELBOW PROSTHESIS received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822632.

Who is the listed applicant for ELBOW PROSTHESIS?

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 ELBOW PROSTHESIS?

The FDA product code for ELBOW PROSTHESIS is IRE.

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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.

K821704FRACTURE BRACINGK801788HUMEROUS FRACTURE BRACE, ULNA FRACTUREK780890CAPP TERMINAL DEVICEK780892FRACTURE BRACINGK780891POST-OPERATIVE HIP ORTHOSISK761312ORTHOTIC BRACING

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Related Devices (Code: IRE)

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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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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