510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880739Substantially Equivalent

Dyonics Drill Guide/isometer System

Dyonics, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880739 is the FDA 510(k) clearance record for DYONICS DRILL GUIDE/ISOMETER SYSTEM, a class I device, cleared for Dyonics, Inc. on under FDA product code LXI (Guide, Drill, Ligament). FDA records list 19 510(k) clearances for Dyonics, Inc., from to . As of , FDA records show no recalls naming K880739.

Clearance record

Decision date
Received
(26 days to decision)
Product code
LXI Guide, Drill, Ligament
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dyonics, Inc. 160 Dascomb Rd., Andover MA
Third party review
No

Clearances, product code LXI

Trailing 12 months

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

FDA records show no clearances under product code LXI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXI, 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