FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
QUANTUM® Patient Specific Instrumentation (PSI) System
K Number: K211883
·
Decision Aug 11, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
67
Applicant Total
18
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUANTUM® Patient Specific Instrumentation (PSI) System
- K Number
- K211883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3110
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In2bones Sas
- Date Received
- June 21, 2021
- Decision Date
- August 11, 2021
- Product Code
- HSN
- 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 |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSN), ordered by most recent decision date.
Prophecy Incompass Surgical Planning System
FDA 510(k)
FDA Class 2
·Orthopedic
Kinos Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Incompass Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
APEX 3D Total Ankle Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Hintermann Series H2 Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Prophecy Surgical Planning System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by In2bones Sas
| K Number | Device Name | ||
|---|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | Apr 23, 2024 | Substantially Equivalent |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | Apr 6, 2023 | Substantially Equivalent |
| K191380 | Quantum® Total Ankle Prosthesis | Jan 29, 2020 | Substantially Equivalent |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | Mar 15, 2018 | Substantially Equivalent |
| K173616 | DIP Arthrodesis System | Jan 19, 2018 | Substantially Equivalent |
| K170688 | PITStop® implant | Nov 28, 2017 | Substantially Equivalent |
| K173121 | Ankle Fusion Plating System | Nov 28, 2017 | Substantially Equivalent |
| K170594 | I.B.S. osteosynthesis screws | May 10, 2017 | Substantially Equivalent |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | Oct 6, 2016 | Substantially Equivalent |
| K160995 | NEOVIEW Plating System | Jun 10, 2016 | Substantially Equivalent |