Search Results
Found 1 results
510(k) Data Aggregation
K Number
K100215Device Name
ARCHIMED REMEDY CERVICAL PLATE
Manufacturer
Date Cleared
2010-04-07
(72 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
ARCHIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions.
Device Description
The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical Plate System implant components are made from titanium alloy described by ASTM F136.
Ask a Question
Ask a specific question about this device
Page 1 of 1