510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781955Substantially Equivalent

Gun, Cement

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

K781955 is the FDA 510(k) clearance record for GUN, CEMENT, a class I device, cleared for Depuy, Inc. on under FDA product code KIH (Dispenser, Cement). FDA records list 67 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K781955.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KIH Dispenser, Cement
Regulation
21 CFR 888.4200
Device class
Class I
Review panel
Orthopedic
Applicant
Depuy, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KIH

Trailing 12 months

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

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