Identity
- Trade Name
- Sectra Orthopedic Package FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 16.1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350092810401 FDA UDI
- 510(k) Number
- K031590 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system workstation
Sectra Orthopedic Package by Sectra AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031590 also covers:
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
- Sectra Orthopedic Package — Sectra AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sectra AB
Sources (1)
- FDA UDI edc2f1c1-9d41-4df4-bd86-0a1a5bd650af 35 fields · synced May 30, 2026