FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K Number: K060683
·
Decision Apr 18, 2006
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
33
Review Days
34
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Basic Information
- Device Name
- ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K Number
- K060683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endius, Inc.
- Date Received
- March 15, 2006
- Decision Date
- April 18, 2006
- 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 Endius, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080258 | MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | Mar 10, 2008 | Substantially Equivalent |
| K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | Feb 11, 2008 | Substantially Equivalent |
| K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | Jan 30, 2008 | Substantially Equivalent |
| K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Dec 7, 2007 | Substantially Equivalent |
| K070282 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | Sep 6, 2007 | Substantially Equivalent |
| K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Apr 12, 2007 | Substantially Equivalent |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | Jun 6, 2006 | Substantially Equivalent |
| K060990 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | Apr 26, 2006 | Substantially Equivalent |
| K053267 | ENDIUS ATAVI SYSTEM | Jan 13, 2006 | Substantially Equivalent |
| K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Oct 1, 2004 | Substantially Equivalent |