ACO Planner
- Primary DI
- E314ACOPLANNER0
- Brand
- ACO Planner
- Company
- Materialise NV
- Model
- ACO Planner
- Catalog number
- ACO Planner
- Device description
- ACO Planner
- Published
- 2017-02-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| PLW | Acetabular Cup Orientation System |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PLW | Acetabular Cup Orientation System | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K150780 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| E314ACOPLANNER0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| CAD/CAM software | A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 373139427
- Device count
- 1
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05420060350856 | TruMatch CMF Titanium 3D Printed Guides | SD980.060 | SD980.060 | 2026-04-29 |
| 05420060351631 | TruMatch CMF Titanium 3D Printed Guides | SD980.064 | SD980.064 | 2026-04-29 |
| 05420060351648 | TruMatch CMF Titanium 3D Printed Guides | SD980.065 | SD980.065 | 2026-04-29 |
| 05420060380747 | TRUMATCH | SD980.028 | SD980.028 | 2025-02-28 |
| 05420060363191 | TruMatch Personalised Solutions Shoulder System | 225501003 | 225501003 | 2022-03-11 |
| E314KNMLM010101 | Lima PSI | KNM-LM01-01-01 | KNM-LM01-01-01 | 2016-12-01 |
| E314KNMLM0101010 | Lima PSI | KNM-LM01-01-01 | KNM-LM01-01-01 | 2017-07-21 |
| E314KNMLM010201 | Lima PSI | KNM-LM01-02-01 | KNM-LM01-02-01 | 2016-12-01 |
| E314KNMLM0102010 | Lima PSI | KNM-LM01-02-01 | KNM-LM01-02-01 | 2017-07-21 |
| E314KNMLM020001 | Lima PSI | KNM-LM02-00-01 | KNM-LM02-00-01 | 2016-12-01 |
| E314KNMLM0200010 | Lima PSI | KNM-LM02-00-01 | KNM-LM02-00-01 | 2017-07-21 |
| E314SHCLM010101 | Lima PSI | SHC-LM01-01-01 | SHC-LM01-01-01 | 2016-12-01 |
| E314SHCLM0101010 | Lima PSI | SHC-LM01-01-01 | SHC-LM01-01-01 | 2017-07-21 |
| E314SHCLM020101 | Lima PSI | SHC-LM02-01-01 | SHC-LM02-01-01 | 2016-12-01 |
| E314SHCLM0201010 | Lima PSI | SHC-LM02-01-01 | SHC-LM02-01-01 | 2017-07-21 |
| 05420060381041 | TruMatch | SD980.104 | SD980.104 | 2020-03-16 |
| 05420060351013 | ProPlan CMF | SD900.101 | SD900.101 | 2016-09-13 |
| 05420060351020 | ProPlan CMF | SD900.102 | SD900.102 | 2016-09-13 |
| 05420060351044 | ProPlan CMF | SD900.104 | SD900.104 | 2016-09-13 |
| 05420060351051 | ProPlan CMF | SD900.105 | SD900.105 | 2016-09-13 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 09351327000374 | OPS™ FHA | OPTIMIZED ORTHO PTY LTD | PLW | 2019-11-11 |
| E314HPCCO0100010 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2017-07-21 |
| E314HPCCO0101010 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2017-07-21 |
| E314HPCCO0102010 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2017-07-21 |
| E314O02055700000113000 | SurgiCase | Materialise NV | PLW | 2017-07-21 |
| E314HPCCO010001 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2016-09-24 |
| E314HPCCO010101 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2016-09-24 |
| E314HPCCO010201 | Bespoke | MATERIALISE USA, L.L.C. | PLW | 2016-09-24 |
| E314O0205570000011300 | SurgiCase | Materialise NV | PLW | 2016-09-24 |