FDA.reportPublic FDA data

Ø5.5mm X 50mm CANNULATED REDUCTION SCREW WITH SET SCREW

Primary DI
B064XMPH23555501
Brand
Ø5.5mm X 50mm CANNULATED REDUCTION SCREW WITH SET SCREW
Company
XENCO MEDICAL LLC
Model
XM-PH-235-5550
Published
2025-11-08
Public version status
New
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
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XMPH23555501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
079282130
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B064HB1180002Sorrento Bioglass 2cc (25 x 20 x 4 mm)HB-118-00022026-04-13
B064HB1180005Sorrento Bioglass 5cc (25 x 50 x 4 mm)HB-118-00052026-04-13
B064HB1180010Sorrento Bioglass 10cc (100 x 20 x 5 mm)HB-118-00102026-04-13
B064HB1180012Sorrento Bioglass 12cc (100 x 20 x 6 mm)HB-118-00122026-04-13
B064HB1180020Sorrento Bioglass 20cc (100 x 25 x 8 mm)HB-118-00202026-04-13
B064HB1180024Sorrento Bioglass 24cc (25 x 240 x 4 mm)HB-118-00242026-04-13
B064XMTL111230823mm x 10mm x 8mm Titanium PLIF with InserterXM-TL-111-23082026-04-13
B064XMTL111230923mm x 10mm x 9mm Titanium PLIF with InserterXM-TL-111-23092026-04-13
B064XMTL111231023mm x 10mm x 10mm Titanium PLIF with InserterXM-TL-111-23102026-04-13
B064XMTL111231123mm x 10mm x 11mm Titanium PLIF with InserterXM-TL-111-23112026-04-13
B064XMTL111231223mm x 10mm x 12mm Titanium PLIF with InserterXM-TL-111-23122026-04-13
B064XMTL111231323mm x 10mm x 13mm Titanium PLIF with InserterXM-TL-111-23132026-04-13
B064XMTL111280828mm x 11mm x 8mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28082026-04-13
B064XMTL111280928mm x 11mm x 9mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28092026-04-13
B064XMTL111281028mm x 11mm x 10mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28102026-04-13
B064XMTL111281128mm x 11mm x 11mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28112026-04-13
B064XMTL111281228mm x 11mm x 12mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28122026-04-13
B064XMTL111281328mm x 11mm x 13mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28132026-04-13
B064XM3D31223121CancelleX™ 13mm x 12mm x 12mm x 12* Cervical InterbodyXM-3D-312-23122026-02-06
B064XM3D31225061CancelleX™ 15mm x 13mm x 6mm x 12* Cervical InterbodyXM-3D-312-25062026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043949180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965029N/ATDM Co., Ltd.KWQ2026-06-05
08800043965036N/ATDM Co., Ltd.KWQ2026-06-05
08800043965043N/ATDM Co., Ltd.KWQ2026-06-05
08800043965050N/ATDM Co., Ltd.KWQ2026-06-05
08800043965067N/ATDM Co., Ltd.KWQ2026-06-05
08800043965074N/ATDM Co., Ltd.KWQ2026-06-05
08800043965081N/ATDM Co., Ltd.KWQ2026-06-05
08800043965098N/ATDM Co., Ltd.KWQ2026-06-05
08800043965104N/ATDM Co., Ltd.KWQ2026-06-05
08800043965111N/ATDM Co., Ltd.KWQ2026-06-05
08800043965128N/ATDM Co., Ltd.KWQ2026-06-05
08800043965135N/ATDM Co., Ltd.KWQ2026-06-05
08800043965142N/ATDM Co., Ltd.KWQ2026-06-05
08800043965159N/ATDM Co., Ltd.KWQ2026-06-05
08800043965166N/ATDM Co., Ltd.KWQ2026-06-05
08800043965173N/ATDM Co., Ltd.KWQ2026-06-05
08800043965180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965197N/ATDM Co., Ltd.KWQ2026-06-05
08800043965203N/ATDM Co., Ltd.KWQ2026-06-05
08800043965210N/ATDM Co., Ltd.KWQ2026-06-05
08800043965227N/ATDM Co., Ltd.KWQ2026-06-05
08800043965234N/ATDM Co., Ltd.KWQ2026-06-05
08800043965241N/ATDM Co., Ltd.KWQ2026-06-05
08800043965258N/ATDM Co., Ltd.KWQ2026-06-05
08800043965265N/ATDM Co., Ltd.KWQ2026-06-05
08800043965272N/ATDM Co., Ltd.KWQ2026-06-05
08800043965289N/ATDM Co., Ltd.KWQ2026-06-05
08800043965296N/ATDM Co., Ltd.KWQ2026-06-05
08800043965302N/ATDM Co., Ltd.KWQ2026-06-05