510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071173Substantially Equivalent

Resolve Tongs, Small/medium, Resolve Tongs, Medium/large, Model Jt-200D, Jt-100D

Ossur Americans (Formerly the Jerome Group), Paulsboro NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071173 is the FDA 510(k) clearance record for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D, a class II device, cleared for Ossur Americans (Formerly the Jerome Group) on under FDA product code HAX (Tong, Skull For Traction). FDA records list one 510(k) clearance for Ossur Americans (Formerly the Jerome Group). As of , FDA records show no recalls naming K071173.

Clearance record

Decision date
Received
(28 days to decision)
Product code
HAX Tong, Skull For Traction
Regulation
21 CFR 882.5960
Device class
Class II
Review panel
Neurology
Applicant
Ossur Americans (Formerly the Jerome Group) 1414 Metropolitan Ave., Paulsboro NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAX

Trailing 12 months

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

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