UNITY Sacroiliac Joint Fixation System
FDA 510(k) K173201 · Huvexel Co. , Ltd.
510(k) numberK173201
Submission
- Device name
- UNITY Sacroiliac Joint Fixation System
- Applicant
- Huvexel Co. , Ltd.
Seongnam-Si, KR - Received
- October 2, 2017
- Decision date
- April 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
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Questions and answers
When was UNITY Sacroiliac Joint Fixation System cleared by the FDA?
UNITY Sacroiliac Joint Fixation System (K173201) received a 510(k) decision of Substantially Equivalent on April 26, 2018, 206 days after the submission was received.
What is the product code of K173201?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.