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510(k) Data Aggregation
K Number
K223392Device Name
REVCON (TM) Screw System
Manufacturer
Voom Medical Devices, Inc.
Date Cleared
2023-02-28
(112 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Voom Medical Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REVCON™ Screw System is indicated for fixation of bone surgery involving reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment
- · Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis.
The REVCON™ Screw System is not intended for spinal use.
Device Description
The REVCON™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device, to allow surgeons to perform a bunion osteotomy and fixation of the osteotomy with a minimally surgical technique. The REVCON™ Screw System contains fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) as per ASTM F136 and are provided non-sterile for end user sterilization.
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