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510(k) Data Aggregation
K Number
K962644Device Name
VIGOR COMPRESSION HIP SCREW SYSTEM
Manufacturer
DEUTSCHLAND SURGICAL, INC.
Date Cleared
1996-09-06
(60 days)
Product Code
JDO
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEUTSCHLAND SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vigor Compression Hip Screw is indicated as a means of rigid internal fixation of stable and unstable fractures of the proximal femur in which a stable medial buttress can be reconstructed and is intended for the management of intertrochanteric, subtrochanteric and basilar neck fractures and selected trochanteric non-unions.
Device Description
The Vigor Compression Hip Screw System is intended as a means of rigid internal fixation for fractures of the proximal femur. The Vigor System implants consist of Bone Screws; Compression Screws, Lag Screws and Side Plates, and are offered in a wide, incremental range of sizes to ensure optimum selection for a proper fixation. The Vigor full-length threaded Bone Screws and Compression Bone Screws are available in a range of sizes from 22.0 mm to 60.0 mm in length. Vigor Lag Screws and Super Lag Screws feature a flattened, square base that engages the inner surface of the implant barrel for increased rotational stability. These Lag Screws are available in a range of sizes from 50.0 mm to 150.0 mm in length, in 5.0 mm increments. And, finally, a trio of low-profile Side Plates are included in the system. Vigor offers the standard 4-hole, 5-hole and 6hole plates, each available in a 135°, 140° or 145° configuration.
The Vigor System instrumentation set consists of the standard instrumentation required for each indicated procedure.
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