FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STREAMLINE MIS SPINAL FIXATION SYSTEM
K Number: K130286
·
Decision Apr 1, 2013
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
16
Review Days
55
Basic Information
- Device Name
- STREAMLINE MIS SPINAL FIXATION SYSTEM
- K Number
- K130286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PIONEER SURGICAL TECHNOLOGY, INC
- Date Received
- February 5, 2013
- Decision Date
- April 1, 2013
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | Mar 27, 2014 | Substantially Equivalent |
| K133623 | C-PLUS | Feb 10, 2014 | Substantially Equivalent |
| K132050 | NB3D BONE VOID FILLER | Feb 7, 2014 | Substantially Equivalent |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Jan 27, 2014 | Substantially Equivalent |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Dec 24, 2013 | Substantially Equivalent |
| K131100 | STREAMLINE TL SPINAL SYSTEM | Jun 27, 2013 | Substantially Equivalent |
| K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | Nov 7, 2012 | Substantially Equivalent |
| K122293 | PIONEER STERNAL CABLE PLATE SYSTEM | Oct 12, 2012 | Substantially Equivalent |
| K120016 | PIONEER STERNAL ASSIST IMPLANT SYSTEM | Jul 26, 2012 | Substantially Equivalent |