510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810450Substantially Equivalent

Truncal Orthosis

Fred Sammons, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810450 is the FDA 510(k) clearance record for TRUNCAL ORTHOSIS, a class I device, cleared for Fred Sammons, Inc. on under FDA product code IQE (Orthosis, Lumbar). FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K810450.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IQE Orthosis, Lumbar
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
Fred Sammons, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IQE

Trailing 12 months

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

FDA records show no clearances under product code IQE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IQE, 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