510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080918Substantially Equivalent

Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0

DePuy Mitek, Inc., Raynham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080918 is the FDA 510(k) clearance record for DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0, a class II device, cleared for Depuy Mitek on under FDA product code NEW (Suture, Surgical, Absorbable, Polydioxanone). FDA records list 80 510(k) clearances for Depuy Mitek, from to . As of , FDA records show no recalls naming K080918.

Clearance record

Decision date
Received
(22 days to decision)
Product code
NEW Suture, Surgical, Absorbable, Polydioxanone
Regulation
21 CFR 878.4840
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Depuy Mitek 325 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEW

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