FDA.reportPublic FDA data

SETx Lateral Mass - Individual Set Screw

Primary DI
B064XM21700131
Brand
SETx Lateral Mass - Individual Set Screw
Company
XENCO MEDICAL LLC
Model
XM-217-0013
Published
2025-11-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XM21700131PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8582021505SALES@XENCOMEDICAL.COM

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
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40202026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40222026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40242026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45202026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45222026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45242026-07-28
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

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00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
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10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
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00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
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