PLIF Cage 100149-250910
PLIF Cage 100149-250910 is a Class II device made by Eisertech, LLC, cleared under FDA 510(k) K113478 on 5 Mar 2012 and listed in FDA GUDID since 13 Apr 2018 (UDI-DI B523100149250910), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB523100149250910 | Date13 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113478 | Date5 Mar 2012 | StatusActive |
Official records
- FDA 510(k) database K113478
Across registries
- FDA 510(k) K113478 decided 5 Mar 2012 Active
- FDA GUDID UDI-DI B523100149250910 listed 13 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K113478
- Listed FDA GUDID B523100149250910
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PLIF Cage
- Generic name
- Metallic spinal fusion cage, non-sterile
- Model / Ref / Catalog
- 100149-250910
- Primary DI / UDI-DI
- B523100149250910
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Metallic spinal fusion cage, non-sterile
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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