FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CSTS SCREW
K Number: K093055
·
Decision Nov 22, 2010
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
7
Review Days
418
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Basic Information
- Device Name
- CSTS SCREW
- K Number
- K093055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopro, LLC
- Date Received
- September 30, 2009
- Decision Date
- November 22, 2010
- 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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|---|---|---|---|
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| K073228 | DC ULNAR SHORTENING SYSTEM | Feb 29, 2008 | Substantially Equivalent |
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| K071243 | METAL HEMI IMPLANT | May 23, 2007 | Substantially Equivalent |
| K062908 | ORTHROPRO HEMI TOE | Nov 13, 2006 | Substantially Equivalent |