FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K Number: K111675
·
Decision Aug 2, 2011
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
23
Review Days
48
Basic Information
- Device Name
- VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
- K Number
- K111675
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theken Spine, LLC
- Date Received
- June 15, 2011
- Decision Date
- August 2, 2011
- 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 Theken Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY | Aug 28, 2012 | Substantially Equivalent |
| K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Jun 27, 2012 | Substantially Equivalent |
| K120829 | STAINLESS STEEL SPINAL SYSTEM | May 30, 2012 | Substantially Equivalent |
| K120047 | CORAL SPINAL SYSTEM | Feb 3, 2012 | Substantially Equivalent |
| K103228 | PARAMOUNT R IBF DEVICE | Jan 5, 2011 | Substantially Equivalent |
| K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | Dec 16, 2010 | Substantially Equivalent |
| K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Sep 2, 2010 | Substantially Equivalent |
| K100970 | STAINLESS STEEL SPINAL SYSTEM | Aug 12, 2010 | Substantially Equivalent |
| K091266 | THEKEN CORAL SPINAL SYSTEM | Jun 10, 2009 | Substantially Equivalent |
| K083863 | THEKEN ATOLL OCT SPINAL SYSTEM | Mar 27, 2009 | Substantially Equivalent |