FDA.reportPublic FDA data

ABS Med Distraction Pin

Primary DI
00818614022642
Brand
ABS Med Distraction Pin
Company
MEDLINE INDUSTRIES, INC.
Model
MDS9091414
Device description
ABS Med Distraction Pin, 14MM Patient (Inner)
Published
2023-08-29
Public version status
Update
Distribution status
Not 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
LYQAccessories, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYQAccessories, Fixation, Spinal Intervertebral BodyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818614022649PackageGS110Not in Commercial Distribution
00818614022642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081861402264910818614022649
00818614022642008186140226428186140226420818614022642

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 (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (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 non-bioabsorbable material (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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426709neoWave Lumbar, StraightXENIX MEDICAL LLCLYQ2026-04-29
00859373004029PasserEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004036HolderEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004043Symbol PlateEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004050DriverEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004067Tensioner ClipEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004074TensionerEMPIRICAL SPINE, INC.LYQ2026-03-27
00840493416441LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493416458LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493413952RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-12-02
00818345029590RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029606RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029620RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029637RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029644RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
G616G1090912DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090914DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090916DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G190912DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190914DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190916DS0PTSPt. Solutions, LLCLYQ2025-10-06
00818345029583RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029613RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029934RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029958RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413747RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413808RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493415413RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
G616S1090912DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090914DS1PTSPt. Solutions, LLCLYQ2025-03-10