CDSCO UID IMP/MD/2023/000436_9a926ec397a3e179ad9b96d3ec74be31_13c4ea54cb535ca1557f13f6c71f18c4
Fixation Device
Zimmer India Private Limited·Device Class Class B·India CDSCO·Brand: General Sports Medicine Instruments
Registration details
- UID
- IMP/MD/2023/000436_9a926ec397a3e179ad9b96d3ec74be31_13c4ea54cb535ca1557f13f6c71f18c4
- Device class
- Class B
- Brand name
- General Sports Medicine Instruments
- License holder
- Zimmer India Private Limited
- Approving authority
- CDSCO
- Product information
- The ToggleLoc System devices, except the ToggleLoc XL device, are intended for soft tissue to bone fixation for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (General Sports Medicine Instruments ) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (General Sports Medicine Instruments ) Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Knee ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (General Sports Medicine Instruments ) or Posterior Cruciate (General Sports Medicine Instruments ) Reconstruction, as well as in cases of unanticipated intraoperative complications, such as cortical breaching
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About this record
Fixation Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000436_9a926ec397a3e179ad9b96d3ec74be31_13c4ea54cb535ca1557f13f6c71f18c4. This device is marketed under the brand name General Sports Medicine Instruments . The license holder is Zimmer India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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