FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHWAY IVB/VBR
K Number: K092904
·
Decision Dec 22, 2009
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
12
Review Days
92
Basic Information
- Device Name
- PATHWAY IVB/VBR
- K Number
- K092904
- 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
- September 21, 2009
- Decision Date
- December 22, 2009
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Custom Spine, Inc.
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|---|---|---|---|
| K143143 | PATHWAY ELIF | Jul 22, 2015 | Substantially Equivalent |
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| K111726 | PATHWAY AVID | Feb 6, 2012 | Substantially Equivalent |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | May 5, 2011 | Substantially Equivalent |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | Aug 17, 2009 | Substantially Equivalent |
| K090566 | PATHWAY AVID | Jun 1, 2009 | Substantially Equivalent |
| K080281 | PATHWAY | May 1, 2008 | Substantially Equivalent |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | Dec 13, 2007 | Substantially Equivalent |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | Jun 11, 2007 | Substantially Equivalent |