FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRATINE FOREHEAD
K Number: K060249
·
Decision Jun 12, 2006
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
17
Review Days
132
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Basic Information
- Device Name
- ULTRATINE FOREHEAD
- K Number
- K060249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coapt Systems, Inc.
- Date Received
- January 31, 2006
- Decision Date
- June 12, 2006
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Coapt Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083783 | VF LIQUIGEL | Sep 11, 2009 | Substantially Equivalent |
| K080956 | MODIFICATION TO VF GEL PLUS | Apr 25, 2008 | Substantially Equivalent |
| K071663 | VF GEL PLUS | Feb 15, 2008 | Substantially Equivalent |
| K060248 | ULTRATINE TRANSBLEPH | Jun 12, 2006 | Substantially Equivalent |
| K060828 | MODIFICATION TO ENDOTINE RIBBON | Apr 19, 2006 | Substantially Equivalent |
| K051415 | ENDOTINE RIBBON | Jun 23, 2005 | Substantially Equivalent |
| K050611 | ENDOTINE RIBBON | Apr 6, 2005 | Substantially Equivalent |
| K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE | Nov 5, 2004 | Substantially Equivalent |
| K041835 | ENDOTINE MIDFACE B 4.5 DEVICE | Sep 28, 2004 | Substantially Equivalent |
| K042078 | ENDOTINE FOREHEAD TRIPLE DEVICE | Aug 27, 2004 | Substantially Equivalent |