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510(k) Data Aggregation
K Number
K063273Device Name
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
Manufacturer
Date Cleared
2006-11-22
(23 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
**DEPUY MILTEK, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: rotator cuff repair
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, , biceps tenodesis, acromio-clavicular separation .
Elbow: Biceps tendon reattachment
Ankle: Achilles tendon repair/reconstruction, lateral stabilization, medial stabilization at the medial talus site
Knee: Medial collateral ligament repair, lateral collateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITB tenodesis, patellar ligament and tendon avulsion repairs
Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, , capsule shift repair (glenoid rim)
Device Description
Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded, PLA disposable suture anchor/ inserter assemblies designed to allow soft tissue repair to bone. The anchors are an identical anchors as that of the Panalok RC Anchor Plus (K041117) and Panalok Anchor (K970896) in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture, Panacryl Suture, Orthocord Suture.
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