Search Results
Found 2 results
510(k) Data Aggregation
K Number
K230993Device Name
CODA Anterior Cervical Plate System
Manufacturer
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Date Cleared
2023-06-20
(75 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
Ask a Question
K Number
K220244Device Name
DVR® Crosslock Wrist Spanning Plate (131849181)
Manufacturer
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Date Cleared
2022-04-28
(90 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.
Device Description
The DVR® Crosslock Wrist Spanning Plate is a single-use plate for the fixation of fractures, osteotomies and non-unions of the distal radius. The plate spans the patient's wrist and is placed from the radial shaft to the second or third metacture pattern and patient anatomy. The plate provides ligamentotaxis on a temporary basis while the distal radius heals. The DVR® Crosslock Wrist Spanning Plate consists of a single, sterile-packed plate and is manufactured from titanium alloy (Ti-6AL-4V). The plate features hole clusters consisting of locking screw holes, a central screw cluster, and K-wire holes for preliminary fixation. There is a dorsal bend at the distal end of the plate to accommodate patient anatomy.
Ask a Question
Page 1 of 1