FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LP CAGE
K Number: K110067
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
12
Review Days
88
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Basic Information
- Device Name
- LP CAGE
- K Number
- K110067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medyssey Co, Ltd.
- Date Received
- January 10, 2011
- Decision Date
- April 8, 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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| K121246 | MEDYSSY LT CAGE SYSTEM | Jun 15, 2012 | Substantially Equivalent |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Jun 8, 2011 | Substantially Equivalent |
| K110283 | ZENIUS SPINAL SYSTEM | May 19, 2011 | Substantially Equivalent |
| K103272 | ZENIUS SPINAL SYSTEM | Dec 29, 2010 | Substantially Equivalent |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Dec 16, 2010 | Substantially Equivalent |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | Jun 25, 2010 | Substantially Equivalent |