FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRITIUM STERNAL CABLE PLATE SYSTEM
K Number: K133785
·
Decision Jan 27, 2014
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
26
Review Days
46
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Basic Information
- Device Name
- TRITIUM STERNAL CABLE PLATE SYSTEM
- K Number
- K133785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pioneer Surgical Technology, Inc.
- Date Received
- December 12, 2013
- Decision Date
- January 27, 2014
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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| K192396 | Streamline MIS Spinal Fixation System | Nov 26, 2019 | Substantially Equivalent |
| K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | Apr 10, 2014 | Substantially Equivalent |
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| K133623 | C-PLUS | Feb 10, 2014 | Substantially Equivalent |
| K132050 | NB3D BONE VOID FILLER | Feb 7, 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 |