FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RTS Flexible 1 MPJ Implant w/Grommets
K Number: K153609
·
Decision Sep 8, 2016
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
20
Applicant Total
25
Review Days
266
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Basic Information
- Device Name
- RTS Flexible 1 MPJ Implant w/Grommets
- K Number
- K153609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3720
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In2bones USA, LLC
- Date Received
- December 17, 2015
- Decision Date
- September 8, 2016
- Product Code
- KWH
- 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 |
|---|---|---|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | FDA class 2 | Orthopedic |
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