LEOS Cannulated Screw System · 76345542SH
Tyber Medical, LLC · LEOS 5.5 X 42mm HLESS Cann Screw, SH, Ti
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- MR Conditional
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- LEOS 5.5 X 42mm HLESS Cann Screw, SH, Ti
- Public device record key
- ee3eb4b1-260f-4456-a9a2-ff5b905a5b45
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 6
- Labeler duns number
- 010968002
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- 76345542SH
- Has manufacturing date
- true
- Brand name
- LEOS Cannulated Screw System
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- 76345542SH
- Company name
- Tyber Medical, LLC
- Public version status
- Update
- Has expiration date
- false
- Is hct p
- false
- Publish date
- 2023-12-08
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 00196449005918
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- HWC
- Name
- Screw, fixation, bone
- Harmonized identifiers (openFDA)
- Device name
- Screw, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Customer contacts
- Phone
- +1(866)761-0933
- preese@tybermed.com
- Gmdn terms
- Code
- 66947
- Name
- Orthopaedic bone screw (non-sliding)
- Implantable
- true
- Code status
- Active
- Definition
A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.