FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
K Number: K080790
·
Decision Apr 29, 2008
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
23
Review Days
40
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Basic Information
- Device Name
- MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
- K Number
- K080790
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theken Spine, LLC
- Date Received
- March 20, 2008
- Decision Date
- April 29, 2008
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 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 |
| K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE | Aug 2, 2011 | 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 |