FDA.report

LIGAFIX

Primary DI
03760154003643
Brand
LIGAFIX
Company
S.B.M
Model
LIGAFIX tibial aiming device-evolution
Catalog number
LIG9000214
Device description
LIGAFIX tibial aiming device-evolution to be used with LIGAFIX interference screws in ACL reconstruction.
Published
2023-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03760154003643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760154003643037601540036433760154003643

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
772462123
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
03760304681714PULLUPPin Set PULLUP90012025-11-20
03760304681721LIGAFIX / PULLUPPin Set PULLIG90022025-11-20
03760304681769LIGAFIX / PULLUPPin Set PULLIG90072025-11-20
03760154001885LIGAFIXLIGAFIX ratchet screwdriver rod Diameter 7-8 mmLIG90003102025-06-26
03760154001892LIGAFIXLIGAFIX ratchet screwdriver rod Diameter 9-10-11 mLIG90003112025-06-26
03760154001915LIGAFIXLIGAFIX ratchet screwdriver handleLIG90003122025-06-26
03760154002806LIGAFIXLIGAFIX ratchet tap rod Diameter 7-8 mmLIG90003192025-06-26
03760154002813LIGAFIXLIGAFIX ratchet tap rod Diameter 9-10-11 mmLIG90003202025-06-26
03760304681615FIXIT / ecoFIXSuture passer automatic grasper - ShoulderEPA90004542025-06-26
03760304681622MENIXSuture passer automatic grasper - KneeMEN90004552025-06-26
03760304681639MENIX / FIXIT / ecoFIXNon sterile needle (x1)ANS90014612025-06-26
03760304681646MENIX / FIXIT / ecoFIXNon sterile needle (x5)ANS90054612025-06-26
03760304681653MENIX / FIXIT / ecoFIXNon sterile needle (x10)ANS90104612025-06-26
03760304681684LIGAFIXRigid guide pin X1LIG9111300-012025-06-26

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