510(k) K140649

Device: VECTRIX EXTERNAL FIXATOR
Applicant: 3D MEDICAL CONCEPTS, LLC
510(k) number: K140649
Product code: NDK
Decision: Substantially Equivalent (SESE)
Decision date: 2014-12-29
Date received: 2014-03-13
Regulation: 888.3040
Classification name: System, External Fixator (with Metallic Invasive Components)
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Abbreviated
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BEVERLY LAIRD
Address: 1061 Morgan Park Rd. Pelham AL US 35242 35242

FDA Registration Numbers#

3010131978
3021226419
1220246

Source Documents#

Other 510(k) Records For Product Code NDK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K122208	EXTERNAL FIXATOR SYSTEM	Christopher D. Endara	2012-12-20
K101375	TRIMED X-FIX	TriMed, Inc.	2010-09-15

Legacy Summary#

summary

FDA Review#

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