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510(k) Data Aggregation

    K Number
    K002413
    Device Name
    ULTRASORB SUTURE ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2000-09-19

    (43 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993373
    Device Name
    ROTORBLADE SUTURE ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-10-27

    (20 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder: rotator cuff repair
    Device Description
    Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
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    K Number
    K992938
    Device Name
    ROTORBLADE SUTURE ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-09-23

    (23 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder - rotator cuff repair
    Device Description
    Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
    Ask a Question
    K Number
    K983435
    Device Name
    ROTORBLADE
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-04-29

    (212 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder: rotator cuff repair
    Device Description
    Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
    Ask a Question
    K Number
    K981755
    Device Name
    LM ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-07-13

    (56 days)

    Product Code
    MBI, GAT, HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
    Device Description
    Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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    K Number
    K981764
    Device Name
    LM ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-07-13

    (55 days)

    Product Code
    MBI, GAT, HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder - bankart repair Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment Skull - lateral canthoplasty Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
    Device Description
    Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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    K Number
    K963288
    Device Name
    LM BONE ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-11-13

    (84 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.
    Device Description
    Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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    K Number
    K963812
    Device Name
    LM BONE ANCHOR (ORTHOPEDICS)
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-11-12

    (64 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraFix RC: Shoulder (rotator cuff repair) UltraFix Mini: Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament) UltraFix: Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
    Device Description
    Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
    Ask a Question
    K Number
    K960825
    Device Name
    LM ANCHOR OR OTHER PROPRIETARY NAME
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-04-30

    (61 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis), Bladder Neck Suspension.
    Device Description
    Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
    Ask a Question
    K Number
    K960439
    Device Name
    LM BONE ANCHOR
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-04-18

    (78 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
    Device Description
    Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
    Ask a Question

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