FDA.reportPublic FDA data

IlluminOss

Primary DI
M986CT03090
Brand
IlluminOss
Company
ILLUMINOSS MEDICAL, INC.
Model
CT-0309
Catalog number
CT-0309
Device description
GUIDEWIRE, TROCAR TIP, 2.0mm
Published
2022-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
M986CT03090PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859664661
Device count
1
Lot or batch
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
M986UM080700Photodynamic Bone Stabilization SystemUM08070UM080702025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02
07630894822582APTUSMedartis AGLXH2026-11-02
07630894822599APTUSMedartis AGLXH2026-11-02
07630894822629APTUSMedartis AGLXH2026-11-02
07630894822636APTUSMedartis AGLXH2026-11-02
07630894822643APTUSMedartis AGLXH2026-11-02
07630894822650APTUSMedartis AGLXH2026-11-02
07630894822681APTUSMedartis AGLXH2026-11-02
07630894823787APTUSMedartis AGLXH2026-11-02
00824846010746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00824846010753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00810017915446Pituitary Straight, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915453Pituitary Straight, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017915460Kerrison, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915477Kerrison, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017916085SABER-XA Angled Self-Retaining Driver, No. 20 HexalobeELEVATION SPINE, INC.LXH2026-10-30
00811382039348NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
03700569680121Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
03700569680138Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
B382SD9144842000Surgical DirectSurgical Direct, Inc.LXH2026-10-30