FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K Number: K111136
·
Decision Jun 14, 2012
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
62
Review Days
419
Basic Information
- Device Name
- EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
- K Number
- K111136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- DEPUY SPINE, INC.
- Date Received
- April 22, 2011
- Decision Date
- June 14, 2012
- 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 DEPUY SPINE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K142185 | EXPEDIUM VERSE SPINE SYSTEM | Nov 19, 2014 | Substantially Equivalent |
| K121020 | VIPER SYSTEM | May 3, 2012 | Substantially Equivalent |
| K110353 | MOUNTAINEER OCT SPINAL SYSTEM | Apr 7, 2011 | Substantially Equivalent |
| K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM | Apr 1, 2011 | Substantially Equivalent |
| K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM | Jan 18, 2011 | Substantially Equivalent |
| K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM | Dec 7, 2010 | Substantially Equivalent |
| K103100 | MOUNTAINEER OCT SPINAL SYSTEM | Nov 17, 2010 | Substantially Equivalent |
| K101762 | VIPER F2 FACET FIXATION SYSTEM | Nov 15, 2010 | Substantially Equivalent |
| K102701 | VIPER SPINE SYSTEM | Oct 20, 2010 | Substantially Equivalent |
| K101933 | MODIFICATION TO:EXPEDIUM SPINE SYSTEM | Oct 18, 2010 | Substantially Equivalent |