510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K950646Substantially Equivalent

Integrator

Moyco Union Broach, Div., Moyco Technologies, Inc., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950646 is the FDA 510(k) clearance record for INTEGRATOR, cleared for Moyco Union Broach, Div., Moyco Technologies, Inc. on under FDA product code LXM (Manipulator, Plunger-Like Joint). FDA records list one 510(k) clearance for Moyco Union Broach, Div., Moyco Technologies, Inc. As of , FDA records show no recalls naming K950646.

Clearance record

Decision date
Received
(442 days to decision)
Product code
LXM Manipulator, Plunger-Like Joint
Device class
Unclassified
Review panel
Unknown
Applicant
Moyco Union Broach, Div., Moyco Technologies, Inc. 589 Davies Dr., York PA
510(k) summary
Statement
Third party review
No

Clearances, product code LXM

Trailing 12 months

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

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