ClearanceBrief
Company

Ossur H / F

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IQIOrthosis, Limb Brace7
ISWAssembly, Knee/Shank/Ankle/Foot, External6
KQZComponent, Traction, Non-Invasive6
IQKOrthosis, Cervical4
ISHComponent, External, Limb, Ankle/Foot2
ITWJoint, Ankle, External Brace2
IPYOrthosis, Lumbo-Sacral1
ISYJoint, Knee, External Limb Component1
ITQJoint, Knee, External Brace1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 1, 2024Ossur H / F
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Open, Classified
IQKNone listed
May 10, 2024Ossur H / F
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Open, Classified
ISWNone listed
May 10, 2024Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Open, Classified
ISWNone listed
May 10, 2024Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Open, Classified
ISWNone listed
May 10, 2024Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Open, Classified
ISWNone listed
Jan 25, 2024Ossur H / F
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Open, Classified
ISWNone listed
Jun 13, 2023Ossur H / F
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
Open, Classified
ISHNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Mar 14, 2016Ossur H / F
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Terminated
KQZNone listed
Feb 24, 2016Ossur H / F
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose
Terminated
IQKNone listed
Feb 24, 2016Ossur H / F
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Terminated
IPYNone listed
Feb 24, 2016Ossur H / F
Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
Terminated
ITWNone listed
Feb 24, 2016Ossur H / F
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
Terminated
ITWNone listed
Feb 24, 2016Ossur H / F
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
Terminated
IQINone listed
Feb 24, 2016Ossur H / F
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Terminated
IQKNone listed
Feb 24, 2016Ossur H / F
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Terminated
IQKNone listed
Feb 24, 2016Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Terminated
ITQNone listed
Feb 24, 2016Ossur H / F
Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in m
Terminated
IQINone listed
Mar 25, 2015Ossur H / F
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and envi
Terminated
ISWNone listed
Mar 17, 2015Ossur H / F
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with
Terminated
ISHNone listed
Feb 6, 2012Ossur H / F
Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
Terminated
ISYNone listed
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