FDA.reportPublic FDA data

Halo Systems

Primary DI
05690977223370
Brand
Halo Systems
Company
OSSUR AMERICAS, INC.
Model
505500V2
Catalog number
505500V2
Device description
OB V2 RING KIT TI LG
Published
2019-02-08
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
05690977223370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05690977223370056909772233705690977223370

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