Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K113299
    Device Name
    ROG SUTURE ANCHOR
    Manufacturer
    ROG SPORTS MEDICINE, INC.
    Date Cleared
    2011-12-15

    (37 days)

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

    ROG SPORTS MEDICINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - . Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. - . Foot/ankle indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair. - . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure. The RoG™ 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: - Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications: Scapholunate ligament reconstruction. . - . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. - . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement. The RoGTM 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction. - . Foot/ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. - Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
    Device Description
    The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
    Ask a Question
    K Number
    K112991
    Device Name
    MODIFIED ROG SUTURE ANCHOR
    Manufacturer
    ROG SPORTS MEDICINE, INC.
    Date Cleared
    2011-12-08

    (63 days)

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

    ROG SPORTS MEDICINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - . Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction. - Eoot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. - Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure. The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: - Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications: Scapholunate ligament reconstruction. . - Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction. - Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement. The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/Hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction. - Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair. - Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
    Device Description
    The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
    Ask a Question
    K Number
    K111590
    Device Name
    ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
    Manufacturer
    ROG SPORTS MEDICINE, INC.
    Date Cleared
    2011-08-08

    (62 days)

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

    ROG SPORTS MEDICINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction. . scapholunate ligament reconstruction. - . Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair. - Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: - Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications:- Scapholunate ligament reconstruction. . - Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction. - . Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. Iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement. The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - Shoulder indications:- Bankart repair. rotator cuff repair. SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - . Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction. scapholunate ligament reconstruction. - Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ● ligament reconstruction, lateral epicondylitis repair. - Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
    Device Description
    The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
    Ask a Question
    K Number
    K110230
    Device Name
    ROG KNOTLESS SUTURE ANCHOR
    Manufacturer
    ROG SPORTS MEDICINE, INC.
    Date Cleared
    2011-05-19

    (113 days)

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

    ROG SPORTS MEDICINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction. - Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - Elbow indications : Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair. - Knee indications:- Lateral collateral ligament repair, medial collateral ligament ● repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
    Device Description
    The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameter of 5.5mm lengths of 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding size.
    Ask a Question
    K Number
    K110229
    Device Name
    ROG SUTURE ANCHOR 5.5MM, 2.9MM
    Manufacturer
    ROG SPORTS MEDICINE, INC.
    Date Cleared
    2011-05-18

    (112 days)

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

    ROG SPORTS MEDICINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RoG 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: - . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. - Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. - t Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. - Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure. The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: - Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. - Wrist/hand indications:- Scapholunate ligament reconstruction. . - . Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. - Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
    Device Description
    The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding sizes.
    Ask a Question

    Page 1 of 1