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Found 6 results
510(k) Data Aggregation
K Number
K962705Device Name
MLI MODULAR STAPLE
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-10-01
(81 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedicineLodge, Inc. (MLI) Modular Staples are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.
Device Description
The MLI Modular Staple is a three piece device consisting of a staple, a washer and a set screw that are designed to be used as an assembly unit. Each of the implant components are manufactured from Ti-6Al-4V ELI, per ASTM F-136 and are discussed in turn below.
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K Number
K961920Device Name
CROSS PIN
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-09-17
(123 days)
Product Code
JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedicineLodge, Inc. (MLI) - Cross Pin is used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries.
Device Description
The MedicineLodge, Inc. (MLI) Cross Pin is a partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone.
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K Number
K961905Device Name
MEDICINELODGE, INC. SET SCREW
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-08-06
(82 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962194Device Name
MLI SOFT TISSUE SCREW & WASHER SYSTEM
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-07-30
(53 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.
Device Description
The MLI Soft Tissue Screw and Washer System is an assembly unit consisting of MLI Soft Tissue Anchoring Screws and MLI Washers. The screws are provided in standard sizes (4.5 mm Cortical and 6.5 mm Cancellous) and conform to ISO 5835. They are self-tapping and inserted manually with a 3.5 mm hex driver. The washers are universally compatible with both screw sizes and come in three design configurations (Round, Triangular, Oval) with spikes on the distal side to penetrate bone and anchor the graft.
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K Number
K961025Device Name
EXPANDED BODY SUTURE
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-04-15
(32 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.
Device Description
The EXPANDED BODY suture is a braided, nonabsorbable, sterile, surgical suture composed of Poly(ethylene terapthalate) intended for use in rotator cuff soft-tissue repair procedures. This device is prepared from fibers of high molecular weight, fong-chain, linear polyesters having recurrent aromatic rings as an integral component.
The EXPANDED BODY suture is identical to currently marketed polyester sutures within this device class with the exception of the following:
1) a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
2) a new design which incorporates an expanded midsection equidistant from both ends of the suture possessing a larger outer diameter (two to four times) than the standard USP size.
The outer diameter of the expanded midsection thus has a cross-sectional area equal to or greater than the cross-sectional area of the needle or drill used to create the hole in the tissue. This ensures that the expanded midsection firmly engages the hole created by the drill or needle in the tissue.
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K Number
K953350Device Name
MLI INTERFERENCE SCREW
Manufacturer
MEDICINE LODGE, INC.
Date Cleared
1996-01-30
(197 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDICINE LODGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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