Simplant Dr. James
510(k) K053592
Simplant Dr. James is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Materialise NV, cleared under FDA 510(k) K053592 on 8 Feb 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053592 | Date8 Feb 2006 | StatusActive |
Official records
- FDA 510(k) database K053592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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