FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K Number: K100708
·
Decision Jun 4, 2010
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
50
Review Days
84
Basic Information
- Device Name
- PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
- K Number
- K100708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PIONEER SURGICAL TECHNOLOGY
- Date Received
- March 12, 2010
- Decision Date
- June 4, 2010
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
Resolve Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Frida Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
X-PAC® N-GAGE Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Skyway Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Elegance® Anterior Cervical plate
FDA 510(k)
FDA Class 2
·Orthopedic
Cervical Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K100361 | NANOSS BONE VOID FILLER | Apr 22, 2010 | Substantially Equivalent |
| K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | Feb 19, 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 |