FDA.reportPublic FDA data

Photodynamic Bone Stabilization System

Primary DI
M986UM080700
Brand
Photodynamic Bone Stabilization System
Company
ILLUMINOSS MEDICAL, INC.
Model
UM08070
Catalog number
UM08070
Device description
8mmx70mm Photodynamic Bone Stabilization LED Light System
Published
2025-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M986UM080700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859664661
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
M986UM080800Photodynamic Bone Stabilization SystemUM08080UM-080802025-01-21