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510(k) Data Aggregation
K Number
K150455Device Name
RT2 Trabeculite Titanium Cervical Cage System
Manufacturer
RHAUSLER, INC.
Date Cleared
2015-11-19
(272 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
RHAUSLER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.
This device is intended to be used with supplemental spinal fixation systems.
Device Description
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V).
The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.
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K Number
K111272Device Name
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
Manufacturer
RHAUSLER, INC.
Date Cleared
2011-11-29
(209 days)
Product Code
OVE
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
RHAUSLER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.
Device Description
The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile.
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