Search Results
Found 2 results
510(k) Data Aggregation
K Number
K172620Device Name
SyndesMetrics Syndesmosis Repair System
Manufacturer
Date Cleared
2017-11-08
(69 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Mortise Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for:
Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Device Description
The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Ask a Question
Ask a specific question about this device
K Number
K171964Device Name
LigaMetrics Suture Anchors
Manufacturer
Date Cleared
2017-09-19
(81 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Mortise Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
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 collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair
Device Description
The LigaMetrics Suture Anchors are offered in Threaded and Push-In versions and are designed to secure soft tissue to bone. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Ask a Question
Ask a specific question about this device
Page 1 of 1