FDA.reportPublic FDA data

LIGAFIX

Primary DI
03760154002493
Brand
LIGAFIX
Company
S.B.M
Model
Lanceolate eyelet pin X10
Catalog number
LIG9000U36-10
Device description
Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X10 to be used with LIGAFIX interference screws for ACL reconstruction.
Published
2023-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
03760154002493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760154002493037601540024933760154002493

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length360Millimeter
Outer Diameter2.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
772462123
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760154001083OTISImpactor bodyEVO90694442023-12-19
03760154001090OTISImpactor tipEVO90694462023-12-19
03760304681738LIGAFIX / PULLUPPin Set PULLIG90032025-12-11
03760304681745LIGAFIXPin Set LIG90000042025-12-11
03760304681752LIGAFIXPin Set LIG90000052025-12-11
03760304681776PULLUPPin Set PULLUP90082025-12-11
03760304681592PULLUPReusable suture retriever pin x5PUL90053032025-12-10
03760304681608PULLUPReusable suture retriever pin x10PUL90103032025-12-10
03760304681615ecoPass LSuture passer automatic grasper Large (Shoulder)EPA90004542025-06-26
03760304681622ecoPass SSuture passer automatic grasper - KneeMEN90004552025-06-26
03760304681639ecoPassNon sterile needle (x1)ANS90014612025-06-26
03760304681646ecoPassNon sterile needle (x5)ANS90054612025-06-26
03760304681653ecoPassNon sterile needle (x10)ANS90104612025-06-26
03760304681769BTLOOPPin Set PULLIG90072025-11-20
03760154006224OTIS-C-PLUSDrill bitEVO90351002023-12-21
03760154006248OTIS-C-PLUSCountersink bitEVO90402032023-12-21
03760304680045RetroTechDrill bitLIG90002942023-12-21
03760154003704PULLUPReusable suture retriever pin x1PUL90003032023-12-20
03760154005791LIGAFIXDrill bitLIG9009289 2023-12-20
03760154005814LIGAFIXRouter bitLIG90100722023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542794964Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794971Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794988Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542794995Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795343Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795350Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795442Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795459Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795541Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795640Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795657Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795718Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795725Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795732Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795893Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797262Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797279Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797286Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542799723Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542799754Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542799785Surgical Manual InstrumentMedacta International SALXH2026-09-28
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25