TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
FDA 510(k) clearance K122850 · decided 2013-03-28
Clearance details
- K-number
- K122850
- Device name
- TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
- Applicant
- Meditech Advisors, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-09-18
- Decision date
- 2013-03-28
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.