510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812401Substantially Equivalent

Cruciform Anterior Spinal Hyperexten. O

Surgical Appliance Industries, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812401 is the FDA 510(k) clearance record for CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O, a class I device, cleared for Surgical Appliance Industries, Inc. on under FDA product code IPT (Orthosis, Thoracic). FDA records list 9 510(k) clearances for Surgical Appliance Industries, Inc., from to . As of , FDA records show no recalls naming K812401.

Clearance record

Decision date
Received
(25 days to decision)
Product code
IPT Orthosis, Thoracic
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
Surgical Appliance Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPT

Trailing 12 months

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

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