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 orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. FDA UDI
- Model / Reference
- 9.2 FDA UDI
- Description
- Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350092810029 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
Similar devices
Also classified as Radiology picture archiving and communication system workstation.
- WorkstationOne™ — Three Palm Software · Class II
- OTOPLAN — CAScination AG · Class II
- Nio Color 2MP LED — Barco, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
- Aline Ablation Intelligence — Mirada Medical, Ltd. · Class II
- CHILI PACS — CHILI GmbH · Class II
- Nio Color 2MP — Barco, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sectra AB
Sources (1)
- FDA UDI 22d27913-ff12-45aa-9639-231bab1bf808 35 fields · synced May 30, 2026