Sagittilt
FDA 510(k) K141787 · Orfit Industries NV
510(k) numberK141787
Submission
- Device name
- Sagittilt
- Applicant
- Orfit Industries NV
Fort Myers, FL, US - Received
- July 2, 2014
- Decision date
- August 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Sagittilt cleared by the FDA?
Sagittilt (K141787) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 36 days after the submission was received.
What is the product code of K141787?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.