FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOPOLY PEDICLE SCREW SYSTEM
K Number: K081108
·
Decision Jul 14, 2008
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
6
Review Days
87
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Basic Information
- Device Name
- MONOPOLY PEDICLE SCREW SYSTEM
- K Number
- K081108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signus Medical, LLC
- Date Received
- April 18, 2008
- Decision Date
- July 14, 2008
- 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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Other Clearances by Signus Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K052096 | NUBIC SPINAL IMPLANT | Aug 16, 2005 | Substantially Equivalent |
| K031455 | CONKLUSION PEDICLE SCREW SYSTEM | Oct 22, 2003 | Substantially Equivalent |
| K031757 | PEEK TETRIS SPINAL IMPLANT | Jul 30, 2003 | Substantially Equivalent |
| K022793 | TETRIS SPINAL IMPLANT | Apr 8, 2003 | Substantially Equivalent |
| K020836 | RABEA CEMENT RESTRICTOR | Jun 11, 2002 | Substantially Equivalent |