FDA.reportPublic FDA data

Halo Systems

Primary DI
05690977197312
Brand
Halo Systems
Company
OSSUR AMERICAS, INC.
Model
505300D
Catalog number
505300D
Device description
OB RESOLVE STERILE UNIT SML
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
HAXTONG, SKULL FOR TRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAXTong, Skull For TractionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051918000RESOLVE OPEN BACK HALO RINGSJerome Medical2005-08-17HAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05690977197312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05690977197312056909771973125690977197312

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
00650551003861HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004417HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004424HALO RINGPMT CORPORATIONHAX2025-03-10
00650551004790HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042006HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042556HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042563HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042570HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042587HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042594HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042600HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042617HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042624HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042631HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042648HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042655HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042792HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042808HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042815HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042822HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042839HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042846HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042853HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042860HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042877HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042884HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042891HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551045052HALO RINGPMT CORPORATIONHAX2025-03-10
00650551045069HALO RINGPMT CORPORATIONHAX2025-03-10
00650551093923HALO SYSTEM COMPONENTPMT CORPORATIONHAX2025-03-10