FDA.reportPublic FDA data

Photodynamic Bone Stabilization System

Primary DI
M986AC13100700
Brand
Photodynamic Bone Stabilization System
Company
ILLUMINOSS MEDICAL, INC.
Model
AC1310070
Catalog number
AC-1310070
Device description
13/10mmx70mm Photodynamic Bone Stabilization LED 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
M986AC13100700PrimaryHIBCC0

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
Premarket exempt
true
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
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
M986UM080800Photodynamic Bone Stabilization SystemUM08080UM-080802025-01-21