FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFEMUR® GLADIATOR® Cemented Classic Stem
K Number: K201519
·
Decision Dec 10, 2020
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
37
Review Days
185
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Basic Information
- Device Name
- PROFEMUR® GLADIATOR® Cemented Classic Stem
- K Number
- K201519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microport Orthopedics, Inc.
- Date Received
- June 8, 2020
- Decision Date
- December 10, 2020
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K213816 | MPO Hip Instruments | Jan 5, 2022 | Substantially Equivalent |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Oct 1, 2021 | Substantially Equivalent |