Copperhead C5509
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB014C5509 | Date8 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090064 | Date9 Apr 2009 | StatusActive |
Recalls
-
- Terminated Z-1417-2013
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Copperhead
- Generic name
- Metallic spinal fusion cage, non-sterile
- Model / reference
- C5509
- Primary DI / UDI-DI
- B014C5509
- 510(k) Number
- FDA product code
- ODP, MQP, MAX
- GMDN term
- Metallic spinal fusion cage, non-sterile
- Device class
- Class II
- Regulation number
- 888.3080, 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Eminent Spine LLC
Properties
Other properties (10)
- Supplied sterile: No
- Implantable: 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