Company ยท US
Ossur Americas
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2013. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Ossur Americas OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA01001L
OSSUR Power Knee REF PKA01001T Open, Classified |
ISW | None listed |
| May 30, 2022 | Ossur Americas OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. Terminated |
ISH | None listed |
| Nov 9, 2021 | Ossur Americas Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use Terminated |
IQK | None listed |
| Jun 1, 2021 | Ossur Americas OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine.
REF:
MJS-101;
MJSR-101 Terminated |
IQK | None listed |
| Jun 21, 2018 | Ossur Americas Ossur, LIL Angel Vest,
Part/ Description:
545100K/ LIL ANGEL VEST P2 KODEL;
545100L/ LIL ANGEL VEST P2 LAMBSWOOL;
545100S/ LIL ANGEL VEST P2 SORBATEX;
545150K/ LIL ANGEL VEST P3 KODEL;
545150L/ LIL Terminated |
KQZ | None listed |
| Jun 21, 2018 | Ossur Americas Ossur, ReSolve Halo Vest,
Part/ Description:
545700K/ ReSolve Halo Vest-shrt kodel;
545700L/ ReSolve Halo Vest-shrt lmbwool;
545800K/ ReSolve Halo Vest-tall kodel;
545800L/ ReSolve Halo Vest-tall lm Terminated |
KQZ | None listed |
| Jun 21, 2018 | Ossur Americas 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 TRAY Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas 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 Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas 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 Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas 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;
515400 Terminated |
HAX | K051918 |
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Ceramic Tip Pin,
Part/ Description:
516CS/ Skull Pin 2-1/4in CT Sterl 1PK;
516DS/ Skull Pin 3in CT Sterl 1PK;
517CS/ Skull Pin 2-1/4in CT Sterl 4PK;
517DS/ Skull Pin 3in CT Terminated |
LYT | K040363 |
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Titanium Pin,
Part/Description:
516TS/ Skull Pin 2-1/4in TI Sterl 1PK;
516V2S/ Skull Pin 3in TI Sterl 1PK;
520TS/ Skull Pin 2-1/4in TI Sterl 5PK;
520V2S/ Skull Pin 3in TI St Terminated |
JEC | K822780 |
| Feb 26, 2014 | Ossur Americas, Inc. The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees.
Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate im Terminated |
None listed | |
| Feb 6, 2014 | Ossur Americas, Inc. The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees.
The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products Terminated |
ISH | None listed |