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Sectra Orthopedic Package
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 121
by Sectra AB
Identity
- Trade Name
- Sectra Orthopaedic Package 19.1 EUDAMEDSectra Orthopedic Package FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Sectra Orthopaedic Package EUDAMEDSectra 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
- 121 EUDAMED19.1 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
- 07350092810609 EUDAMEDFDA UDI
- Basic UDI-DI
- 735009281Orthopedic_App84 EUDAMED
- Direct Marketing DI
- 07350092810609 EUDAMED
- 510(k) Number
- K031590 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12139092 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiology picture archiving and communication system workstation.
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- Nio Color 2MP — Barco, Inc. · Class II
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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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sectra AB
Sources (2)
- FDA UDI b6ff6bbc-55e9-4258-8511-6eb77a8924cd 35 fields · synced Jun 19, 2026
- EUDAMED a29a5da1-64ef-4e3e-ba04-3145815cde77 61 fields · synced Jun 19, 2026