FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Corin Optimized Positioning System (OPS) Femoral
K Number: K193545
·
Decision Aug 4, 2020
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
57
Review Days
228
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Basic Information
- Device Name
- Corin Optimized Positioning System (OPS) Femoral
- K Number
- K193545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- December 20, 2019
- Decision Date
- August 4, 2020
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Corin USA
| K Number | Device Name | ||
|---|---|---|---|
| K203751 | OMNIVision system | Apr 12, 2021 | Substantially Equivalent |
| K202805 | Optimized Positioning System (OPS) Insight | Nov 20, 2020 | Substantially Equivalent |
| K193042 | Optimized Positioning System (OPS) ReView | Jun 26, 2020 | Substantially Equivalent |
| K192656 | Optimized Positioning System (OPS) Insight | May 1, 2020 | Substantially Equivalent |
| K190143 | LARS AC Band Device | Nov 4, 2019 | Substantially Equivalent |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Jul 22, 2019 | Substantially Equivalent |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Nov 26, 2018 | Substantially Equivalent |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Sep 7, 2018 | Substantially Equivalent |
| K152893 | Corin Optimized Positioning System (OPS) | Jun 3, 2016 | Substantially Equivalent |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | Apr 29, 2016 | Substantially Equivalent |