510(k) K223326
- Device
- Axiom PSR System
- Applicant
- Restor3D
- 510(k) number
- K223326
- Product code
- OYK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-30
- Date received
- 2022-10-31
- Regulation
- 888.3110
- Classification name
- Ankle Arthroplasty Implantation System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brianna Prindle
- Address
- 404 Hunt St. Suite 500 Durham NC US 27701 27701
FDA Registration Numbers#
- 3010667733
- 1424434
- 1043534
- 3014833750
- 1724955
- 3008650117
- 1051526
- 3010470577
- 1057425
- 3012275107
Source Documents#
Other 510(k) Records For Product Code OYK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-10-25 |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-10-25 |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-08-30 |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-08-30 |
| K231585 | Vantage PSI System | 3D Systems, Inc. | 2023-06-30 |
| K193432 | Vantage PSI System | 3D Systems | 2020-11-09 |