FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROPOSED OPTIMUS
K Number: K132596
·
Decision Apr 11, 2014
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
12
Review Days
235
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Basic Information
- Device Name
- PROPOSED OPTIMUS
- K Number
- K132596
- 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
- August 19, 2013
- Decision Date
- April 11, 2014
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, 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 |
| 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 |
| 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 |