510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974186Substantially Equivalent

Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating

Orthofix SRL, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974186 is the FDA 510(k) clearance record for ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING, a class II device, cleared for Orthofix Srl on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 102 510(k) clearances for Orthofix Srl, from to . As of , FDA records show no recalls naming K974186.

Clearance record

Decision date
Received
(131 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Orthofix Srl 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code JDW

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