Half Dome BH112409A
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Overview
A comprehensive intervertebral fusion device designed for the treatment of degenerative disc disease, featuring a hollow, porous, threaded, and/or fenestrated cylindrical or disc-shaped metal cage made of titanium. The device provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur, with bone graft typically used to aid osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841379180906 | Date3 Aug 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Half Dome
- Generic Name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- BH112409A
- Primary DI / UDI-DI
- 00841379180906
- FDA Product Code
- MAX
- GMDN Term
- Metallic spinal interbody fusion cage
- Device Class
- Class II
- Regulation Number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Width — 11 MillimeterLength — 24 MillimeterHeight — 14 MillimeterAngle — 0 degree
Other devices from Astura Medical
Properties
Other properties (10)
- Sterile: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No