PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
FDA 510(k) clearance K041167 · decided 2004-07-23
Clearance details
- K-number
- K041167
- Device name
- PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
- Applicant
- Pioneer Surgical Technology
- Decision
- Substantially Equivalent
- Date received
- 2004-05-04
- Decision date
- 2004-07-23
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- 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 |
|---|---|---|
| Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog nu recall (Z-0021-06) | Pioneer Surgical Technology | 2005-10-07 |