FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Icona Hip Stem
K Number: K241472
·
Decision Oct 3, 2024
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
21
Review Days
132
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Basic Information
- Device Name
- Icona Hip Stem
- K Number
- K241472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin U.S.A. Limited
- Date Received
- May 24, 2024
- Decision Date
- October 3, 2024
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K242744 | Trinity EVO Acetabular Shell | Jun 5, 2025 | Substantially Equivalent |
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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 |
| K183114 | Corin BiPolar-i | Jun 5, 2019 | Substantially Equivalent |
| K183533 | Unity Total Knee System | Jun 4, 2019 | Substantially Equivalent |