510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892411Substantially Equivalent

Mennen Bone Fixation Device

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892411 is the FDA 510(k) clearance record for MENNEN BONE FIXATION DEVICE, a class II device, cleared for Dentsply Intl. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K892411.

Clearance record

Decision date
Received
(273 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No

Clearances, product code JDQ

Trailing 12 months
1 clearance under product code JDQ in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260