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510(k) Data Aggregation
K Number
K011603Device Name
VHS PEDIATRIC HIP SCREW SYSTEM
Manufacturer
WALTER ABENDSCHEIN, M.D.
Date Cleared
2001-08-15
(83 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
WALTER ABENDSCHEIN, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :
1. Congenital coxa vara.
2. Congenital dislocation of the hip
3. Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
4. Coxa plana ( Legg-Calve-Perthes disease )
Device Description
The VHS™ Pediatric Hip Screw System is a compression fixation system used for the treatment of femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws. Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
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K Number
K002184Device Name
COD COMPRESSION OSTEOTOMY DEVICE
Manufacturer
WALTER ABENDSCHEIN, M.D.
Date Cleared
2000-11-24
(128 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
WALTER ABENDSCHEIN, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000827Device Name
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
Manufacturer
WALTER ABENDSCHEIN, M.D.
Date Cleared
2000-06-23
(101 days)
Product Code
KRR
Regulation Number
888.3540Why did this record match?
Applicant Name (Manufacturer) :
WALTER ABENDSCHEIN, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991806Device Name
VHS SUPRACONDYLAR PLATE SYSTEM
Manufacturer
WALTER ABENDSCHEIN, M.D.
Date Cleared
1999-08-06
(72 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
WALTER ABENDSCHEIN, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
Device Description
The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
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K Number
K964880Device Name
VARI-ANGLE HIP SCREW (VHS) SYSTEM
Manufacturer
WALTER ABENDSCHEIN, M.D.
Date Cleared
1997-10-16
(315 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
WALTER ABENDSCHEIN, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
Device Description
The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
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