510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811297Substantially Equivalent

Cervical Support

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

K811297 is the FDA 510(k) clearance record for CERVICAL SUPPORT, a class I device, cleared for Orthomedics on under FDA product code IQF (Orthosis, Cervical-Thoracic, Rigid). FDA records list 16 510(k) clearances for Orthomedics, from to . As of , FDA records show no recalls naming K811297.

Clearance record

Decision date
Received
(16 days to decision)
Product code
IQF Orthosis, Cervical-Thoracic, Rigid
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
Orthomedics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IQF

Trailing 12 months

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

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