FDA.reportPublic FDA data

Flex-Thread

Primary DI
00840118121972
Brand
Flex-Thread
Company
FLOWER ORTHOPEDICS CORPORATION
Model
HANSLD
Device description
K-Wire, 1.6mm x 150mm, Smooth
Published
2023-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118121972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118121972008401181219728401181219720840118121972

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)778-8587info@flowerortho.com

Regulatory Flags#

DUNS number
078790947
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118126199Active CompressionOTP0552025-12-01
00840118126298Active CompressionSHADP2025-12-01
00840118126526Active CompressionOC701202025-12-01
00840118116800ZERO Profile Interlocking Cortex Screw, 3.5mm x 10mm, T15, Flex-Thread™8525-10-S2021-03-19
00840118116817ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™8525-12-S2021-03-19
00840118116824ZERO Profile Interlocking Cortex Screw, 3.5mm x 14mm, T15, Flex-Thread™8525-14-S2021-03-19
00840118116831ZERO Profile Interlocking Cortex Screw, 3.5mm x 16mm, T15, Flex-Thread™8525-16-S2021-03-19
00840118116848ZERO Profile Interlocking Cortex Screw, 3.5mm x 18mm, T15, Flex-Thread™8525-18-S2021-03-19
00840118116855ZERO Profile Interlocking Cortex Screw, 3.5mm x 20mm, T15, Flex-Thread™8525-20-S2021-03-19
00840118116862ZERO Profile Interlocking Cortex Screw, 3.5mm x 22mm, T15, Flex-Thread™8525-22-S2021-03-19
00840118116879ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™8525-24-S2021-03-19
00840118116886ZERO Profile Interlocking Cortex Screw, 3.5mm x 26mm, T15, Flex-Thread™8525-26-S2021-03-19
00840118116893ZERO Profile Interlocking Cortex Screw, 3.5mm x 28mm, T15, Flex-Thread™8525-28-S2021-03-19
00840118116909ZERO Profile Interlocking Cortex Screw, 3.5mm x 30mm, T15, Flex-Thread™8525-30-S2021-03-19
00840118116916ZERO Profile Interlocking Cortex Screw, 3.5mm x 32mm, T15, Flex-Thread™8525-32-S2021-03-19
00840118116923ZERO Profile Interlocking Cortex Screw, 3.5mm x 34mm, T15, Flex-Thread™8525-34-S2021-03-19
00840118116930ZERO Profile Interlocking Cortex Screw, 3.5mm x 36mm, T15, Flex-Thread™8525-36-S2021-03-19
00840118116947ZERO Profile Interlocking Cortex Screw, 3.5mm x 38mm, T15, Flex-Thread™8525-38-S2021-03-19
00840118116954ZERO Profile Interlocking Cortex Screw, 3.5mm x 40mm, T15, Flex-Thread™8525-40-S2021-03-19
00840118116961ZERO Profile Interlocking Cortex Screw, 3.5mm x 42mm, T15, Flex-Thread™8525-42-S2021-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23