FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cadence Ankle PSI System
K Number: K243174
·
Decision Oct 25, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
6
Applicant Total
9
Review Days
25
Basic Information
- Device Name
- Cadence Ankle PSI System
- K Number
- K243174
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems, Inc.
- Date Received
- September 30, 2024
- Decision Date
- October 25, 2024
- Product Code
- OYK
- 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 |
|---|---|---|---|
| OYK | Ankle Arthroplasty Implantation System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OYK), ordered by most recent decision date.
Salto Talaris Ankle PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
Salto Talaris Ankle PSI System
FDA 510(k)
FDA Class 2
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Cadence Ankle PSI System
FDA 510(k)
FDA Class 2
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Vantage PSI System
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Axiom PSR System
FDA 510(k)
FDA Class 2
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Vantage PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by 3D Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243173 | Salto Talaris Ankle PSI System | Oct 25, 2024 | Substantially Equivalent |
| K241148 | Salto Talaris Ankle PSI System | Aug 30, 2024 | Substantially Equivalent |
| K241326 | Cadence Ankle PSI System | Aug 30, 2024 | Substantially Equivalent |
| K231834 | VSP PEEK Cranial Implant | Apr 4, 2024 | Substantially Equivalent |
| K231585 | Vantage PSI System | Jun 30, 2023 | Substantially Equivalent |
| K183489 | D2P | Aug 29, 2019 | Substantially Equivalent |
| K190044 | VSP Orthopedics System | Aug 21, 2019 | Substantially Equivalent |
| K151285 | VSP Cranial System | Sep 23, 2016 | Substantially Equivalent |