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Found 30 results
510(k) Data Aggregation
K Number
K013572Device Name
MITEK BIOCRYL INTERFERENCE SCREWS
Manufacturer
MITEK PRODUCTS
Date Cleared
2002-03-14
(136 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Device Description
The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
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K Number
K013781Device Name
RIDIDFIX 2.7MM BTB CROSS PIN KIT
Manufacturer
MITEK PRODUCTS
Date Cleared
2002-02-06
(84 days)
Product Code
HTY, MAI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.
Device Description
The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).
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K Number
K002639Device Name
BIOKNOTLESS ANCHOR
Manufacturer
MITEK PRODUCTS
Date Cleared
2001-05-11
(260 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Device Description
The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.
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K Number
K010633Device Name
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
Manufacturer
MITEK PRODUCTS
Date Cleared
2001-05-09
(68 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).
Device Description
The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).
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K Number
K002406Device Name
MITEK 2GII MENISCAL REPAIR SYSTEM
Manufacturer
MITEK PRODUCTS
Date Cleared
2001-02-15
(192 days)
Product Code
MAI, GAM, GAS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).
Device Description
The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.
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K Number
K003076Device Name
MITEK CUFFTACK
Manufacturer
MITEK PRODUCTS
Date Cleared
2000-10-27
(24 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002402Device Name
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
Manufacturer
MITEK PRODUCTS
Date Cleared
2000-08-31
(24 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002422Device Name
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
Manufacturer
MITEK PRODUCTS
Date Cleared
2000-08-31
(23 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000936Device Name
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
Manufacturer
MITEK PRODUCTS
Date Cleared
2000-04-19
(27 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993575Device Name
RESOLVE QUICKANCHOR
Manufacturer
MITEK PRODUCTS
Date Cleared
1999-12-29
(69 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
MITEK PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
Device Description
The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
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