Search Results
Found 3 results
510(k) Data Aggregation
K Number
K173269Device Name
KATOR Suture Anchor
Manufacturer
KATOR LLC
Date Cleared
2018-05-30
(230 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KATOR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
Device Description
The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.
Ask a Question
K Number
K162386Device Name
KATOR Suture Anchor
Manufacturer
KATOR LLC
Date Cleared
2016-10-25
(61 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KATOR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
Device Description
The modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.
Ask a Question
K Number
K152236Device Name
KATOR Suture Anchor
Manufacturer
KATOR LLC
Date Cleared
2015-11-04
(86 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KATOR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
Device Description
The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.
Ask a Question
Page 1 of 1