EMINENT SPINE INTERBODY FUSION SYSTEM
FDA 510(k) clearance K090064 · decided 2009-04-09
Clearance details
- K-number
- K090064
- Device name
- EMINENT SPINE INTERBODY FUSION SYSTEM
- Applicant
- Eminent Spine
- Decision
- Substantially Equivalent
- Date received
- 2009-01-09
- Decision date
- 2009-04-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leander, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, L recall (Z-1417-2013) | Spinal Solutions, LLC | 2013-05-27 |