FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHROPRO HEMI TOE
K Number: K062908
·
Decision Nov 13, 2006
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
7
Review Days
47
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Basic Information
- Device Name
- ORTHROPRO HEMI TOE
- K Number
- K062908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopro, LLC
- Date Received
- September 27, 2006
- Decision Date
- November 13, 2006
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
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Other Clearances by Orthopro, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K122936 | ANKLE TRAUMA SYSTEM | Feb 28, 2013 | Substantially Equivalent |
| K113006 | I-FUSE HAMMER TOE SYSTEMS | May 25, 2012 | Substantially Equivalent |
| K093055 | CSTS SCREW | Nov 22, 2010 | Substantially Equivalent |
| K073228 | DC ULNAR SHORTENING SYSTEM | Feb 29, 2008 | Substantially Equivalent |
| K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES | Jul 13, 2007 | Substantially Equivalent |
| K071243 | METAL HEMI IMPLANT | May 23, 2007 | Substantially Equivalent |