DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
FDA 510(k) clearance K091638 · decided 2009-09-14
Clearance details
- K-number
- K091638
- Device name
- DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
- Applicant
- Spinefrontier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-04
- Decision date
- 2009-09-14
- Days to decision
- 102 days
- Clearance type
- Abbreviated
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.