OrthoView 7.4.1
OrthoView 7.4.1 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Meridian Technique Limited, cleared under FDA 510(k) K063327 on 22 Nov 2006 and listed in FDA GUDID since 4 Dec 2019 (UDI-DI B021741WEBWK0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB021741WEBWK0 | Date4 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063327 | Date22 Nov 2006 | StatusActive |
Official records
- FDA 510(k) database K063327
Across registries
- FDA 510(k) K063327 decided 22 Nov 2006 Active
- FDA GUDID UDI-DI B021741WEBWK0 listed 4 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K063327
- Listed FDA GUDID B021741WEBWK0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OrthoView
- Generic name
- Orthopaedic/craniofacial implantation planning software
- Model / reference
- 7.4.1
- Primary DI / UDI-DI
- B021741WEBWK0
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Orthopaedic/craniofacial implantation planning software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic/craniofacial implantation planning software.