FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISUALIF CHALLENGING ACCESS PLATE
K Number: K122168
·
Decision Oct 11, 2012
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
9
Review Days
80
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Basic Information
- Device Name
- VISUALIF CHALLENGING ACCESS PLATE
- K Number
- K122168
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Smith Partners L.P.
- Date Received
- July 23, 2012
- Decision Date
- October 11, 2012
- 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 Spine Smith Partners L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K122630 | IN:C2 SPINAL FIXATION SYSTEM | Dec 5, 2012 | Substantially Equivalent |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | Jul 1, 2010 | Substantially Equivalent |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | Apr 1, 2009 | Substantially Equivalent |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Oct 31, 2008 | Substantially Equivalent |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Jul 14, 2008 | Substantially Equivalent |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Jul 2, 2008 | Substantially Equivalent |
| K073320 | CIMPLICITY SPINAL SYSTEM | Feb 7, 2008 | Substantially Equivalent |