FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMPOWR Stem Extender, 50mm
K Number: K230441
·
Decision Mar 17, 2023
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- EMPOWR Stem Extender, 50mm
- K Number
- K230441
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical, L.P Dba Enovis
- Date Received
- February 21, 2023
- Decision Date
- March 17, 2023
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Encore Medical, L.P Dba Enovis
| K Number | Device Name | ||
|---|---|---|---|
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Apr 6, 2023 | Substantially Equivalent |