510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223589Substantially Equivalent

Grappler Suture Anchor R3FLEX IOL System

Paragon 28, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223589 is the FDA 510(k) clearance record for Grappler Suture Anchor R3FLEX IOL System, a class II device, cleared for Paragon 28, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 59 510(k) clearances for Paragon 28, Inc., from to . As of , FDA records show no recalls naming K223589.

Clearance record

Decision date
Received
(92 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Paragon 28, Inc. 14445 Grasslands Dr., Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260