510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K840735Substantially Equivalent

Femoral Cement Removal Instrument

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

K840735 is the FDA 510(k) clearance record for FEMORAL CEMENT REMOVAL INSTRUMENT, a class I device, cleared for Amtech Scientific, Inc. on under FDA product code HWX (Tap, Bone). FDA records list one 510(k) clearance for Amtech Scientific, Inc. As of , FDA records show no recalls naming K840735.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HWX Tap, Bone
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Amtech Scientific, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HWX

Trailing 12 months

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

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