ClearanceBrief
Panels › Physical Medicine › Product code IQK · Class 1

Orthosis, Cervical

Regulation 890.3490

0510(k)s in 12 months (27 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
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Top companies in IQK

Company510(k)sRecalls
Ossur H / F04
Body Therapeutics, Inc.30
Deip Enterprises, Inc.30
Ossur Americas02
Warm & Form, Orthopedic Materials20
Abco Dealers, Inc.10
Bashaw Custom Specialties, Inc.10
Battle Creek Equipment Co.10
Bee Ent.10
Blackstone & Breglio Industries10
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
Nov 9, 2021Ossur Americas
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Terminated
IQKNone listed
Jun 1, 2021Ossur Americas
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Terminated
IQKNone 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
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

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