510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853436Substantially Equivalent

H-H Hunter Passive Tendon Implant

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

K853436 is the FDA 510(k) clearance record for H-H HUNTER PASSIVE TENDON IMPLANT, a class I device, cleared for Holter-Hausner Intl. on under FDA product code HXR (Spatula, Orthopedic). FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K853436.

Clearance record

Decision date
Received
(62 days to decision)
Product code
HXR Spatula, Orthopedic
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Holter-Hausner Intl. Third And Mill St.S, Bridgeport PA
Third party review
No

Clearances, product code HXR

Trailing 12 months

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

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