510(k) K122208

Device: EXTERNAL FIXATOR SYSTEM
Applicant: CHRISTOPHER D. ENDARA
510(k) number: K122208
Product code: NDK
Decision: Substantially Equivalent (SESE)
Decision date: 2012-12-20
Date received: 2012-07-25
Regulation: 888.3040
Classification name: System, External Fixator (with Metallic Invasive Components)
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00888867514508	Arthrex®	ARTHREX, INC.	2025-03-26
00888867514515	Arthrex®	ARTHREX, INC.	2025-03-26
00888867514522	Arthrex®	ARTHREX, INC.	2025-03-26
10888867241401	Arthrex®	ARTHREX, INC.	2021-12-03
00888867329126	Arthrex®	ARTHREX, INC.	2019-11-15
00888867241220	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241039	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241046	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241121	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241169	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241176	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241183	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241190	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241206	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241213	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241909	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241237	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241244	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241107	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241114	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241138	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241145	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241152	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241268	Arthrex®	ARTHREX, INC.	2017-02-15
00888867241275	Arthrex®	ARTHREX, INC.	2017-02-15

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140649	VECTRIX EXTERNAL FIXATOR	3D Medical Concepts, LLC	2014-12-29
K101375	TRIMED X-FIX	TriMed, Inc.	2010-09-15

summary