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Found 5 results
510(k) Data Aggregation
K Number
K192873Device Name
SX-One MicroKnife
Manufacturer
Sonex Health, Inc.
Date Cleared
2019-12-20
(73 days)
Product Code
LXH
Regulation Number
888.4540Why did this record match?
Product Code :
LXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.
Device Description
The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.
The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.
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K Number
K140414Device Name
IMBIBE NEEDLE
Manufacturer
ORTHOVITA, INC.
Date Cleared
2014-04-01
(42 days)
Product Code
LXH, IMB, KNW
Regulation Number
888.4540Why did this record match?
Product Code :
LXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
Device Description
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
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K Number
K101609Device Name
SELF RETAINING SOFT TISSUE RETRACTOR
Manufacturer
KOROS USA, INC.
Date Cleared
2010-12-09
(184 days)
Product Code
LXH
Regulation Number
888.4540Why did this record match?
Product Code :
LXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .
Device Description
Self-Retaining Lumbar Retractor
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K Number
K001507Device Name
MICROPERFORATION INSTRUMENT
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
2000-06-14
(30 days)
Product Code
LXH
Regulation Number
888.4540Why did this record match?
Product Code :
LXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952495Device Name
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
Manufacturer
ORTHOPEDIC SYSTEMS, INC.
Date Cleared
1996-01-22
(237 days)
Product Code
LXH
Regulation Number
888.4540Why did this record match?
Product Code :
LXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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