Cervical Plate 100163-0
Cervical Plate 100163-0 is an orthopaedic fixation plate (FDA Class II; FDA product code KWQ, Appliance, Fixation, Spinal Intervertebral Body) made by Eisertech, LLC, cleared under FDA 510(k) K113170 on 6 Apr 2012 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI B5231001630), 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 | NumberB5231001630 | Date7 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113170 | Date6 Apr 2012 | StatusActive |
Official records
- FDA 510(k) database K113170
Across registries
- FDA 510(k) K113170 decided 6 Apr 2012 Active
- FDA GUDID UDI-DI B5231001630 listed 7 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K113170
- Listed FDA GUDID B5231001630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cervical Plate
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- 100163-0
- Primary DI / UDI-DI
- B5231001630
- 510(k) Number
- FDA product code
- KWQ
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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