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510(k) Data Aggregation
K Number
K150924Device Name
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
Manufacturer
ANCHOR INNOVATION MEDICAL (A.I.M.)
Date Cleared
2015-07-27
(112 days)
Product Code
GZB
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ANCHOR INNOVATION MEDICAL (A.I.M.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.
Device Description
The A.I.M. Lead Loop Suturing Device is a singular anchor threaded with an adjustable loop of non-absorbable size 0 suture. The suture material is commercially available Ultra-High Molecular Weight Polyethylene or Polyester braid. The anchor is composed of carbon fiber reinforced polyetheretherketone (PEEK OPTIMA®) supplied by Invibio®. The device is provided sterile and pre-loaded in a needle-tipped, disposable-delivery device to facilitate insertion into tissue. A sterile, disposable ancillary instrument is available separately, or included with the Lead Loop Suturing Device, to assist with tensioning the construct and trimming the suture once the appropriate tension is achieved.
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K Number
K133770Device Name
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
Manufacturer
ANCHOR INNOVATION MEDICAL (A.I.M.)
Date Cleared
2014-06-10
(181 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ANCHOR INNOVATION MEDICAL (A.I.M.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.
Device Description
The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.
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