FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTEP TBI (Tailors Bunion Implant) System
K Number: K190970
·
Decision Aug 13, 2019
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
302
Review Days
123
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Basic Information
- Device Name
- PROSTEP TBI (Tailors Bunion Implant) System
- K Number
- K190970
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wrightmedicaltechnologyinc
- Date Received
- April 12, 2019
- Decision Date
- August 13, 2019
- 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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