FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K Number: K092295
·
Decision Feb 19, 2010
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
50
Review Days
205
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Basic Information
- Device Name
- PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
- K Number
- K092295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pioneer Surgical Technology
- Date Received
- July 29, 2009
- Decision Date
- February 19, 2010
- Product Code
- KWP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Pioneer Surgical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K110561 | FORTROSS BONE VOID FILLER | Apr 29, 2011 | Substantially Equivalent |
| K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS | Mar 7, 2011 | Substantially Equivalent |
| K101525 | PIONEER SPINOUS PROCESS FUSION PLATE | Oct 22, 2010 | Substantially Equivalent |
| K093692 | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES | Aug 11, 2010 | Substantially Equivalent |
| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | Aug 10, 2010 | Substantially Equivalent |
| K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Jun 4, 2010 | Substantially Equivalent |
| K100361 | NANOSS BONE VOID FILLER | Apr 22, 2010 | Substantially Equivalent |
| K091031 | PIONEER SURGICAL NANOSS BVF-E | Nov 17, 2009 | Substantially Equivalent |
| K083449 | E-MATRIX GRAFT BONE EXTENDER | Jun 12, 2009 | Substantially Equivalent |
| K090222 | PIONEER LUMBAR PLATE SYSTEM | Apr 28, 2009 | Substantially Equivalent |