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Found 3 results
510(k) Data Aggregation
K Number
K150209Device Name
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc
Manufacturer
Depuy Mitek, a Johnson and Johnson Company
Date Cleared
2015-10-06
(249 days)
Product Code
MAI, HTY, JDR, MBI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Depuy Mitek, a Johnson and Johnson Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K140643Device Name
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
Manufacturer
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
Date Cleared
2014-07-08
(118 days)
Product Code
MAI, MBI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
Device Description
The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.
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K Number
K140324Device Name
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
Manufacturer
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
Date Cleared
2014-07-07
(147 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.
Device Description
The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.
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