RESOLVE OPEN BACK HALO RINGS— 510(k) K051918

Clearance details

Applicant

Jerome Medical

Product code

Code HAX

Device class

Class 2

Regulation

21 CFR 882.5960

Advisory panel

Neurology

Date received

2005-07-15

Decision date

2005-08-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Moorestown, NJ, US

• K090733 — PMT HALO SYSTEM2009-07-28
• K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D2007-05-25
• K023959 — JEROME GLASS RING2003-02-21
• K003662 — SPINE WORKS COLLAR2001-07-09
• K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM1999-02-18

• K930021 — J TONGS1995-12-06
• K930153 — SYSTEM III HALO RING1993-08-06
• K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE1988-09-30
• K870053 — TORQUEDRIVER WRENCH1987-03-11
• K864969 — JMS HALO APPLICATION TRAY1987-02-18

• Z-0999-2019 — Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAYClass II·Terminated·Ossur Americas·20180621
• Z-1000-2019 — Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo LgClass II·Terminated·Ossur Americas·20180621
• Z-1001-2019 — Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAYClass II·Terminated·Ossur Americas·20180621
• Z-1002-2019 — Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAYClass II·Terminated·Ossur Americas·20180621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051918.