Entasis 3D Dual-Lead Sacroiliac Implant System
FDA 510(k) K223708 · Corelink, LLC
510(k) numberK223708
Submission
- Device name
- Entasis 3D Dual-Lead Sacroiliac Implant System
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- December 12, 2022
- Decision date
- March 21, 2023
- 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 Entasis 3D Dual-Lead Sacroiliac Implant System cleared by the FDA?
Entasis 3D Dual-Lead Sacroiliac Implant System (K223708) received a 510(k) decision of Substantially Equivalent on March 21, 2023, 99 days after the submission was received.
What is the product code of K223708?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.