Bengal 177300610
Bengal 177300610 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K173787 on 11 Jun 2018 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034060620), 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 | FDA 510(k)SESE | NumberK173787 | Date11 Jun 2018 | StatusActive |
| United States | GUDID listing | Number10705034060620 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 10705034060620
- FDA 510(k) database K173787
- FDA 510(k) database K073649
Across registries
- FDA 510(k) K173787 decided 11 Jun 2018 Active
- FDA GUDID UDI-DI 10705034060620 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K073649
- Listed FDA GUDID 10705034060620
- Cleared FDA 510(k) K173787
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bengal
- Generic name
- Polymeric spinal interbody fusion cage
- Model / Ref / Catalog
- 177300610
- Primary DI / UDI-DI
- 10705034060620
- FDA product code
- MQP
- GMDN term
- Polymeric spinal interbody fusion cage
- 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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- CONCORDE 187850209 by MEDOS INTERNATIONAL SARL