510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243302Substantially Equivalent

3DMatrix DynaFlex (DynaFlex)

Printbio, Inc., Long Island City NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243302 is the FDA 510(k) clearance record for 3DMatrix DynaFlex (DynaFlex), a class II device, cleared for Printbio, Inc. on under FDA product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery). FDA's definition for product code OXF reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". FDA records list 2 510(k) clearances for Printbio, Inc., from to . As of , FDA records show no recalls naming K243302.

Clearance record

Decision date
Received
(215 days to decision)
Product code
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Printbio, Inc. 51-36 35th St., Long Island City NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXF

Trailing 12 months

FDA records hold no clearances under product code OXF in the trailing twelve months.

FDA records show no clearances under product code OXF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260