Medline UNITE REFLEX Dynamic Discs
FDA 510(k) K211612 · Medline Industries, Inc.
510(k) numberK211612
Submission
- Device name
- Medline UNITE REFLEX Dynamic Discs
- Applicant
- Medline Industries, Inc.
Northfiled, IL, US - Received
- May 26, 2021
- Decision date
- December 10, 2021
- 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 Medline UNITE REFLEX Dynamic Discs cleared by the FDA?
Medline UNITE REFLEX Dynamic Discs (K211612) received a 510(k) decision of Substantially Equivalent on December 10, 2021, 198 days after the submission was received.
What is the product code of K211612?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.