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510(k) Data Aggregation
K Number
K002755Device Name
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
Manufacturer
T. KOROS SURGICAL INSTRUMENTS CORP.
Date Cleared
2000-12-04
(90 days)
Product Code
LRN
Regulation Number
888.3030Why did this record match?
Product Code :
LRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990355Device Name
STAINLESS STEEL SOFT SUTURE WIRE
Manufacturer
BREGMA INTERNATIONAL TRADING COMPANY LTD.
Date Cleared
1999-07-08
(153 days)
Product Code
LRN
Regulation Number
888.3030Why did this record match?
Product Code :
LRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.
Device Description
Suture Wire (87 LRN)
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K Number
K971682Device Name
J-FX CERCLAGE SYSTEM
Manufacturer
JOHNSON & JOHNSON PROFESSIONALS, INC.
Date Cleared
1997-06-27
(52 days)
Product Code
LRN
Regulation Number
888.3030Why did this record match?
Product Code :
LRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.
Device Description
The J-Fx Cerclage System consists of implants and instruments. The implants are cables and sleeves in both stainless steel and cobalt chromium alloy. The cables are available in two diameters, 1.6 mm and 2.0 mm. Instrumentation is also part of the system to assist in the placement of the implants.
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