FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COUGAR LS LATERAL CAGE SYSTEM
K Number: K110454
·
Decision May 13, 2011
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- COUGAR LS LATERAL CAGE SYSTEM
- K Number
- K110454
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson
- Date Received
- February 16, 2011
- Decision Date
- May 13, 2011
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Johnson & Johnson
| K Number | Device Name | ||
|---|---|---|---|
| K113273 | SPOTLIGHT ACCESS SYSTEM | Jan 27, 2012 | Substantially Equivalent |
| K112913 | SPOTLIGHT ACCESS SYSTEM | Dec 16, 2011 | Substantially Equivalent |
| K113348 | COUGAR SYSTEM | Dec 13, 2011 | Substantially Equivalent |
| K110551 | EXPEDIUM SPINE SYSTEM | Oct 26, 2011 | Substantially Equivalent |
| K110694 | CONCORDE BULLET SPINAL SYSTEM | Oct 11, 2011 | Substantially Equivalent |
| K111571 | VIPER SYSTEMS | Jul 6, 2011 | Substantially Equivalent |
| K103743 | CONCORDE CURVE SYSTEM | Mar 17, 2011 | Substantially Equivalent |
| K103490 | EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM | Feb 17, 2011 | Substantially Equivalent |