FDA.reportPublic FDA data

Halo Systems

Primary DI
05690977084490
Brand
Halo Systems
Company
OSSUR AMERICAS, INC.
Model
516DS
Catalog number
516DS
Device description
Skull Pin 3in CT Sterl 1PK
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
LYTFIXATION ACCESSORY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYTFixation AccessoryOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040363000CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.2004-04-12LYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05690977084490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05690977084490056909770844905690977084490

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine immobilization head ring pinA threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level; four pins are typically required. It is typically made of, e.g., high-grade surgical steel or titanium (Ti), or it may be ceramic-tipped or made of non-ferromagnetic materials that allow magnetic resonance imaging (MRI) and reduces the possibility of an electric current passing to the patient causing imaging artefact and/or a burning at the point. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
139280028
Device count
1
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
05055662968408Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLYT2022-11-28
05055662963182Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLYT2021-06-25
05055662966343Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLYT2021-06-25
05690977084254Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977084544Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977192577Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977194090Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977368965Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
04546540568083Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568106Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568113Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568120Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568137Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568144Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568151Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568168Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490240Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490257Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490264Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490271Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490288Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490295Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490301Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490318Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490325Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013306Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013313Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013320Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013337Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24