Mega Plus Spine System 95105-100
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809665571014 | Date30 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183080 | Date10 Dec 2018 | StatusActive |
Official records
- AccessGUDID record 08809665571014
- FDA 510(k) database K183080
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mega Plus Spine System
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 95105-100
- Primary DI / UDI-DI
- 08809665571014
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Bk Meditech Co., Ltd.
Properties
Other properties (10)
- Supplied 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