Sectra Orthopedic Package
Basic Information
- Brand Name
- Sectra Orthopedic Package
- Primary DI
- 07350092810432
- Version / Model
- 16.2
- Company Name
- Sectra AB
- Labeler DUNS
- 354117848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 1
- Public Version Date
- 2022-10-26
- Public Version Status
- New
- Public Device Record Key
- bab7fd5f-2c09-4dcd-a34b-603699c03d55
Device Description
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40943 | Radiology picture archiving and communication system workstation | A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350092810432 | GS1 |
Customer Contacts
- Phone
- +4613235206
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031590 | 000 |