FDA.reportPublic FDA data

IlluminOss

Primary DI
M986CT01950
Brand
IlluminOss
Company
ILLUMINOSS MEDICAL, INC.
Model
CT-0195
Catalog number
CT-0195
Device description
Flex Tube Cutter, mini-SF
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-ActivatedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160062000IlluminOss Bone Stabilization SystemIllminoss Medical, Inc.2017-12-19QAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M986CT01950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859664661
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M986CT03290IlluminOssCT-0329CT-03292022-11-10
M986US22132600Photodynamic Bone Stabilization SystemUS22132600US-22132602025-01-21
USSL2213260Photodynamic Bone Stabilization Procedure PackUSSL-2213260USSL22132602019-07-23
M986AC091000Photodynamic Bone Stabilization SystemAC09100AC-091002025-01-21
M986AC091200Photodynamic Bone Stabilization SystemAC09120AC-091202025-01-21
M986AC13100700Photodynamic Bone Stabilization SystemAC1310070AC-13100702025-01-21
M986AC13100900Photodynamic Bone Stabilization SystemAC1310090AC-13100902025-01-21
M986AC13101200Photodynamic Bone Stabilization SystemAC1310120AC-13101202025-01-21
M986UM040400Photodynamic Bone Stabilization SystemUM04040UM-040402025-01-21
M986UM050400Photodynamic Bone Stabilization LED Light SystemUM05040UM-050402025-01-21
M986UM050500Photodynamic Bone Stabilization SystemUM05050UM-050502025-01-21
M986UM060400Photodynamic Bone Stabilization SystemUM06040UM-060402025-01-21
M986UM060500Photodynamic Bone Stabilization SystemUM06050UM-060502025-01-21
M986UM060600Photodynamic Bone Stabilization SystemUM06060UM-060602025-01-21
M986UM070500Photodynamic Bone Stabilization SystemUM07050UM-070502025-01-21
M986UM070600Photodynamic Bone Stabilization SystemUM07060UM-070602025-01-21
M986UM070700Photodynamic Bone Stabilization SystemUM07070UM-070702025-01-21
M986UM080500Photodynamic Bone Stabilization SystemUM08050UM-080502025-01-21
M986UM080600Photodynamic Bone Stabilization SystemUM08060UM-080602025-01-21
M986UM080700Photodynamic Bone Stabilization SystemUM08070UM080702025-01-21

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