FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIJF CANNULATED SCREW SYSTEM
K Number: K051296
·
Decision Aug 26, 2005
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
68
Review Days
100
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Basic Information
- Device Name
- SIJF CANNULATED SCREW SYSTEM
- K Number
- K051296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Spine, Inc.
- Date Received
- May 18, 2005
- Decision Date
- August 26, 2005
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K201831 | CONFIDENCE Spinal Cement System | Aug 31, 2020 | Substantially Equivalent |
| K142185 | EXPEDIUM VERSE SPINE SYSTEM | Nov 19, 2014 | Substantially Equivalent |
| K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | Jun 14, 2012 | Unknown |
| 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 |