Bespoke
- Primary DI
- E314HPCCO0102010
- Brand
- Bespoke
- Company
- MATERIALISE USA, L.L.C.
- Model
- HPC-CO01-02-01
- Catalog number
- HPC-CO01-02-01
- Device description
- Consensus CT THA hip bone model
- Published
- 2017-07-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
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 |
|---|---|---|---|---|
| E314HPCCO010201 | Previous | HIBCC | 0 | |
| E314HPCCO0102010 | Primary | HIBCC | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 946657160
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| E314KNMCO010101 | Bespoke | KNM-CO01-01-01 | KNM-CO01-01-01 | 2016-09-24 |
| E314KNMCO0101010 | Bespoke | KNM-CO01-01-01 | KNM-CO01-01-01 | 2017-07-21 |
| E314KNMCO010201 | Bespoke | KNM-CO01-02-01 | KNM-CO01-02-01 | 2016-09-24 |
| E314KNMCO0102010 | Bespoke | KNM-CO01-02-01 | KNM-CO01-02-01 | 2017-07-21 |
| E314KNMCO020001 | Bespoke | KNM-CO02-00-01 | KNM-CO02-00-01 | 2016-09-24 |
| E314KNMCO0200010 | Bespoke | KNM-CO02-00-01 | KNM-CO02-00-01 | 2017-07-21 |
| E314KNMCO040001 | Bespoke | KNM-CO04-00-01 | KNM-CO04-00-01 | 2016-09-24 |
| E314KNMCO0400010 | Bespoke | KNM-CO04-00-01 | KNM-CO04-00-01 | 2017-07-21 |
| E314KNMCO010301 | Bespoke | KNM-CO01-03-01 | KNM-CO01-03-01 | 2016-09-24 |
| E314KNMCO0103010 | Bespoke | KNM-CO01-03-01 | KNM-CO01-03-01 | 2017-07-21 |
| E314KNMCO010401 | Bespoke | KNM-CO01-04-01 | KNM-CO01-04-01 | 2016-09-24 |
| E314KNMCO0104010 | Bespoke | KNM-CO01-04-01 | KNM-CO01-04-01 | 2017-07-21 |
| E314HPCCO0100010 | Bespoke | HPC-CO01-00-01 | HPC-CO01-00-01 | 2017-07-21 |
| E314HPCCO0101010 | Bespoke | HPC-CO01-01-01 | HPC-CO01-01-01 | 2017-07-21 |
| E314HPCCO010001 | Bespoke | HPC-CO01-00-01 | HPC-CO01-00-01 | 2016-09-24 |
| E314HPCCO010101 | Bespoke | HPC-CO01-01-01 | HPC-CO01-01-01 | 2016-09-24 |
| E314HPCCO010201 | Bespoke | HPC-CO01-02-01 | HPC-CO01-02-01 | 2016-09-24 |
| E314KNMCO010001 | Bespoke | KNM-CO01-00-01 | KNM-CO01-00-01 | 2016-09-24 |
| E314KNMCO0100010 | Bespoke | KNM-CO01-00-01 | KNM-CO01-00-01 | 2017-07-21 |
| E314KNMCO030001 | Bespoke | KNM-CO03-00-01 | KNM-CO03-00-01 | 2016-09-24 |
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 |
| E314O02055700000113000 | SurgiCase | Materialise NV | PLW | 2017-07-21 |
| E314ACOPLANNER0 | ACO Planner | Materialise NV | PLW | 2017-02-10 |
| 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 |