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
K853369Substantially Equivalent

H-H Fixation & Joining Connectors

Holter-Hausner Intl., Bridgeport PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853369 is the FDA 510(k) clearance record for H-H FIXATION & JOINING CONNECTORS, a class II device, cleared for Holter-Hausner Intl. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K853369.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Holter-Hausner Intl. Third And Mill St.S, Bridgeport PA
Third party review
No

Clearances, product code JXG

Trailing 12 months
4 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260