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Found 12 results
510(k) Data Aggregation
K Number
K121354Device Name
MICRO/MINI N-PK(F) BONE ANCHOR
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2012-11-09
(189 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle - . Hallux valgus repairs - Medial or lateral instability repairs/reconstructions . - Achilles tendon repairs/reconstructions - . Midfoot reconstructions - Metatarsa} ligament/tendon repairs/reconstructions . - . Bunionectomy
Device Description
The Micro/Mini N-PK(F) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
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K Number
K121356Device Name
MICRO/MINI N-PK(H) BONE ANCHOR
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2012-11-09
(189 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair
Device Description
The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
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K Number
K113805Device Name
FIXATE TISSUE BAND
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2012-02-23
(62 days)
Product Code
GZB, GAT
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter- spinous/supra- spinous ligament.
Device Description
The fiXate Tissue Band consists of an adjustable loop of non- absorbable 2-0 suture (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub- layer of tissue.
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K Number
K113400Device Name
FIXATE TISSUE BAND
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2011-12-16
(29 days)
Product Code
GZB, GAT
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
Device Description
The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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K Number
K112849Device Name
FIXATE TISSUE BAND
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2011-10-27
(28 days)
Product Code
GZB
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
Device Description
The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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K Number
K111462Device Name
FIXATE TISSUE BAND
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2011-09-08
(105 days)
Product Code
GZB
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
Device Description
The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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K Number
K100572Device Name
VERSACLOSE, MODEL VC-200-01
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2010-03-17
(16 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Device Description
The Versaclose implant is comprised of one (1) Peek Optima (LT1) Toggle-anchor, connected to an adjustable 2-0 braided suture loop, made of ultra high molecular weight polyethylene (UHMWPE) force fiber suture. The suture component conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
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K Number
K091432Device Name
XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2009-06-12
(29 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Device Description
The modified Xclose™ Tissue Repair System consists of two (2) non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument.
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K Number
K082729Device Name
RIMCLOSE BONE ANCHOR
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2008-12-19
(92 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Device Description
The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only.
The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture.
The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.
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K Number
K062307Device Name
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
Manufacturer
ANULEX TECHNOLOGIES, INC
Date Cleared
2006-09-01
(24 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ANULEX TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Device Description
The Xclose™ Tissue Repair System consists of two (2) non- absorbable braided surgical 3-0 suture and T-anchor assemblies, connected together with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together, thereby re-approximating the tissue. The device construct is composed of polyethylene terephthalate (PET) and conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
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