510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822632Substantially Equivalent

Elbow Prosthesis

Hosmer Dorrance Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822632 is the FDA 510(k) clearance record for ELBOW PROSTHESIS, a class I device, cleared for Hosmer Dorrance Corp. on under FDA product code IRE (Joint, Elbow, External Limb Component, Powered). FDA records list 9 510(k) clearances for Hosmer Dorrance Corp., from to . As of , FDA records show no recalls naming K822632.

Clearance record

Decision date
Received
(14 days to decision)
Product code
IRE Joint, Elbow, External Limb Component, Powered
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Applicant
Hosmer Dorrance Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IRE

Trailing 12 months

FDA records hold no clearances under product code IRE in the trailing twelve months.

FDA records show no clearances under product code IRE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IRE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260