FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHWAY
K Number: K080281
·
Decision May 1, 2008
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
12
Review Days
87
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Basic Information
- Device Name
- PATHWAY
- K Number
- K080281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Custom Spine, Inc.
- Date Received
- February 4, 2008
- Decision Date
- May 1, 2008
- 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 Custom Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143143 | PATHWAY ELIF | Jul 22, 2015 | Substantially Equivalent |
| K132596 | PROPOSED OPTIMUS | Apr 11, 2014 | Substantially Equivalent |
| K120597 | KOMPREDA | May 3, 2013 | Substantially Equivalent |
| K111726 | PATHWAY AVID | Feb 6, 2012 | Substantially Equivalent |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | May 5, 2011 | Substantially Equivalent |
| K092904 | PATHWAY IVB/VBR | Dec 22, 2009 | Substantially Equivalent |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | Aug 17, 2009 | Substantially Equivalent |
| K090566 | PATHWAY AVID | Jun 1, 2009 | Substantially Equivalent |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | Dec 13, 2007 | Substantially Equivalent |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | Jun 11, 2007 | Substantially Equivalent |