ANCHORING PIN 30MM/4MM
NA - 6007-430-000
Device Description
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Diameter: 4.0 Millimeter
- Length: 30.0 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: OLO
Device Name: Orthopedic Stereotaxic Instrument
Device Class: 2
Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.
Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.
Regulation Number: 882.4560
Third Party Flag: N
Medical Specialty: NE
Device Identifiers
Device Id: 04546540372956
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
