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510(k) Data Aggregation
K Number
K120078Device Name
HEALIX ADVANCE BR ANCHOR
Manufacturer
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
Date Cleared
2012-02-29
(50 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction:
Hip: Capsular repair, Acetabular Labral Repair.
Device Description
The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE BR Anchor is provided sterile and is for single patient use only.
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