510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K211612Substantially Equivalent

Medline UNITE REFLEX Dynamic Discs

MEDLINE INDUSTRIES, LP - Northfield, Northfiled IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211612 is the FDA 510(k) clearance record for Medline UNITE REFLEX Dynamic Discs, a class II device, cleared for Medline Industries, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K211612.

Clearance record

Decision date
Received
(198 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Medline Industries, Inc. Three Lakes Dr., Northfiled IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260