FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
PROW FUSION-V
K Number: K153786
·
Decision Jul 11, 2016
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
8
Review Days
193
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Basic Information
- Device Name
- PROW FUSION-V
- K Number
- K153786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nlt Spine, Ltd.
- Date Received
- December 31, 2015
- Decision Date
- July 11, 2016
- 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 Nlt Spine, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K153665 | PROW FUSION-L | Sep 15, 2016 | Substantially Equivalent |
| K151654 | PROW FUSION | Jul 17, 2015 | Substantially Equivalent |
| K133061 | ESPIN SYSTEM | Nov 27, 2013 | Substantially Equivalent |
| K130254 | PROW FUSION | Oct 16, 2013 | Substantially Equivalent |
| K130057 | ESPIN | Feb 7, 2013 | Substantially Equivalent |
| K120553 | ESPIN | Aug 9, 2012 | Substantially Equivalent |
| K112359 | PROW FUSION | Nov 8, 2011 | Substantially Equivalent |