MicroLink All-Suture Button Fixation System (Radiolucent)
FDA 510(k) K190516 · Conmed Corporation
510(k) numberK190516
Submission
- Device name
- MicroLink All-Suture Button Fixation System (Radiolucent)
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- March 4, 2019
- Decision date
- June 28, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was MicroLink All-Suture Button Fixation System (Radiolucent) cleared by the FDA?
MicroLink All-Suture Button Fixation System (Radiolucent) (K190516) received a 510(k) decision of Substantially Equivalent on June 28, 2019, 116 days after the submission was received.
What is the product code of K190516?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.