FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROPHECY Preoperative Navigation Alignment System
K Number: K202815
·
Decision Mar 10, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
67
Applicant Total
302
Review Days
167
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Basic Information
- Device Name
- PROPHECY Preoperative Navigation Alignment System
- K Number
- K202815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wrightmedicaltechnologyinc
- Date Received
- September 24, 2020
- Decision Date
- March 10, 2021
- Product Code
- HSN
- 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 |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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