PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
FDA 510(k) clearance K073177 · decided 2008-05-13
Clearance details
- K-number
- K073177
- Device name
- PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
- Applicant
- Pioneer Surgical Technology
- Decision
- Substantially Equivalent
- Date received
- 2007-11-13
- Decision date
- 2008-05-13
- Days to decision
- 182 days
- Clearance type
- Abbreviated
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marquette, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless impla recall (Z-0627-2014) | RTI Surgical, Inc. | 2014-01-03 |