510(k) K132290
- Device
- SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
- Applicant
- MATERIALISE N.V.
- 510(k) number
- K132290
- Product code
- PBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-10
- Date received
- 2013-07-23
- Regulation
- 888.3030
- Classification name
- Orthopaedic Surgical Planning And Instrument Guides
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- OLIVER CLEMENS
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers#
- 3012086398
- 3038011206
- 8043792
- 3013561205
- 1057946
- 3008650117
- 3016090213
- 3009196021
- 3012916784
- 3003998208
- 9617840
- 3006946276
- 3019248313
- 3005180920
- 3010163695
- 3010667733
- 3008744062
- 3009555447
- 1724955
- 1020279
- 3027329005
- 9610905
- 3014273501
- 3008110533
- 3021635140
- 3007143290
- 3014483751
- 1043534
- 3030409224
- 1822565
- 3007366790
- 3009555440
- 3011623994
- 3005718816
Source Documents#
Other 510(k) Records For Product Code PBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252064 | MedCAD® AccuStride™ System | Medcad | 2026-03-27 |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 |
| K242603 | MyPAO SA guides | Medacta International S.A. | 2025-11-19 |
| K251709 | MedCAD® AccuStride™ System | Medcad | 2025-11-04 |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | 2025-10-21 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 |
| K241811 | MedCAD® AccuStride™ System | Medcad | 2025-03-13 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-02-13 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024-11-07 |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024-03-18 |
| K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-02-09 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023-10-25 |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | 2023-09-20 |
| K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023-06-02 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases