FDA.reportPublic FDA data

Distraction Pin , 12MM Pouch

Primary DI
00818614022505
Brand
Distraction Pin , 12MM Pouch
Company
MEDLINE INDUSTRIES, INC.
Model
909-12
Catalog number
909-12-K
Device description
KateMar Distraction Pin , 12MM Pouch
Published
2022-05-06
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
20818614022509PackageGS110Not in Commercial Distribution
00818614022505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081861402250920818614022509
00818614022505008186140225058186140225050818614022505

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.

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

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