FDA.reportPublic FDA data

Halo Systems

Primary DI
05690977196636
Brand
Halo Systems
Company
OSSUR AMERICAS, INC.
Model
538
Catalog number
538
Device description
HALO APPLICATION TRAY
Published
2018-05-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864969000JMS HALO APPLICATION TRAYJerome Medical1987-02-18KDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05690977196636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05690977196636056909771966365690977196636

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine immobilization head ringA loop (halo) that is part of a cervical spine immobilization system (commonly known as a Halo vest) and designed to be fixed to the skull of a patient at brow level using pointed, steel, threaded bolts (typically four) that are adjusted to penetrate the outer bone of the skull. Vertical, adjustable rods from the Halo vest are locked to this loop, and a traction upon the cervical spine is created, holding the head firmly in place relative to the torso so that cervical vertebrae are immobilized following surgery or injury. It may be made of ferrous or non-ferromagnetic materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
139280028
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05690967529864Rheo KneeRKN12100RKN121002018-05-16
05690967566227Rheo KneeRKNLPCWB1RKNLPCWB12018-05-16
05690967595418Rheo KneeRKN130003RKN1300032018-05-16
05690967596644Rheo KneeRKN13100RKN131002018-05-16
05690967598426Rheo KneeRKN130002RKN1300022018-05-16
05690967598433Rheo KneeRKN130005RKN1300052018-05-16
05690967600587Rheo KneeRKN13110RKN131102018-05-16
05690967600594Rheo KneeRKN13210RKN132102018-05-16
05690967610517Rheo KneeRKN13140RKN131402018-05-16
05690967613136Rheo KneeRKN13130RKN131302018-05-16
05690977279728Rheo KneeRKN13240RKN132402018-05-16
05690977467798Rheo KneeRKNXC0002RKNXC00022018-05-16
05690977467804Rheo KneeRKNXC0003RKNXC00032018-05-16
05690977467811Rheo KneeRKNXC0005RKNXC00052018-05-16
05690977467873Rheo KneeRKNXC230RKNXC2302018-05-16
05690967648749Power KneePKA10003PKA100032022-07-08
05690967642822Power KneePKA01001LPKA01001L2021-03-12
05690967642839Power KneePKA01001TPKA01001T2021-03-12
05690967648381Power KneePKA10001PKA100012021-03-12
05690967648404Power KneePKA10002PKA100022021-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327279110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327285029Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327285616Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327286040Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327286415Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327287443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327287788Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327288266Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10195327242763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23
10195327244835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23