510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894228Substantially Equivalent

Kronner Spherical Cutters

Kronner Medical, Roseburg OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894228 is the FDA 510(k) clearance record for KRONNER SPHERICAL CUTTERS, a class I device, cleared for Kronner Medical on under FDA product code HWT (Template). FDA records list 7 510(k) clearances for Kronner Medical, from to . As of , FDA records show no recalls naming K894228.

Clearance record

Decision date
Received
(399 days to decision)
Product code
HWT Template
Regulation
21 CFR 888.4800
Device class
Class I
Review panel
Orthopedic
Applicant
Kronner Medical 544 W. Umpqua, Roseburg OR
Third party review
No

Clearances, product code HWT

Trailing 12 months

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

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