Surgical Navigation Advanced Platform
510(k) K140819
Surgical Navigation Advanced Platform is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Surgical Theater LLC, cleared under FDA 510(k) K140819 on 27 Jun 2014, 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 | NumberK140819 | Date27 Jun 2014 | StatusActive |
Official records
- FDA 510(k) database K140819
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Surgical Theater, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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