FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Unity Total Knee System
K Number: K183533
·
Decision Jun 4, 2019
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
21
Review Days
167
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Basic Information
- Device Name
- Unity Total Knee System
- K Number
- K183533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin U.S.A. Limited
- Date Received
- December 19, 2018
- Decision Date
- June 4, 2019
- 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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|---|---|---|---|
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| K241570 | Unity Total Knee System | Sep 23, 2024 | Substantially Equivalent |
| K240875 | Unity Knee PS-C Tibial Insert | Jun 26, 2024 | Substantially Equivalent |
| K231172 | ApolloKnee | Jul 26, 2023 | Substantially Equivalent |
| K212069 | Corin MetaFix Hip Stem | Apr 7, 2022 | Substantially Equivalent |
| K191831 | MobiliT Cup | Jan 16, 2020 | Substantially Equivalent |
| K191374 | Revival Modular Hip Stem | Jul 22, 2019 | Substantially Equivalent |
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