FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
K Number: K200011
·
Decision Oct 1, 2021
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
37
Review Days
638
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Basic Information
- Device Name
- E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
- K Number
- K200011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microport Orthopedics, Inc.
- Date Received
- January 2, 2020
- Decision Date
- October 1, 2021
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
| K250444 | NEXUS® Hip Stem | May 15, 2025 | Substantially Equivalent |
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| K233507 | EVOLUTION® Tibial Cones | Jan 18, 2024 | Substantially Equivalent |
| K231947 | EVOLUTION® Cement Keel | Oct 31, 2023 | Substantially Equivalent |
| K230563 | EVOLUTION® Hinge Knee System | Sep 27, 2023 | Substantially Equivalent |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Jan 5, 2022 | Substantially Equivalent |
| K213816 | MPO Hip Instruments | Jan 5, 2022 | Substantially Equivalent |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Aug 24, 2021 | Substantially Equivalent |