510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831898Substantially Equivalent

Scolimeter

Dr. Micheal A. Sabia, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831898 is the FDA 510(k) clearance record for SCOLIMETER, a class I device, cleared for Dr. Micheal A. Sabia on under FDA product code KTZ (Caliper). FDA records list 2 510(k) clearances for Dr. Micheal A. Sabia, from to . As of , FDA records show no recalls naming K831898.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KTZ Caliper
Regulation
21 CFR 888.4150
Device class
Class I
Review panel
Orthopedic
Applicant
Dr. Micheal A. Sabia 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTZ

Trailing 12 months

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

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