510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811176Substantially Equivalent

Tigges Spinal

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

K811176 is the FDA 510(k) clearance record for TIGGES SPINAL, a class I device, cleared for The Tiggs Co. on under FDA product code IPW (Orthosis, Sacroiliac, Soft). FDA records list one 510(k) clearance for The Tiggs Co. As of , FDA records show no recalls naming K811176.

Clearance record

Decision date
Received
(17 days to decision)
Product code
IPW Orthosis, Sacroiliac, Soft
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
The Tiggs Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPW

Trailing 12 months

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

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