Data / Medical devices / United States / Mci Medical Concept Innovation Inc.

Mci Medical Concept Innovation Inc.: FDA-registered device maker in Sunrise, FL, United States, 2 510(k) clearances

Name: Mci Medical Concept Innovation Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mci Medical Concept Innovation Inc. is registered with the FDA (registration 1000606483) in Sunrise, FL, United States. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1000606483
Address: 4592 North Hiatus Road, Sunrise, FL, United States, 33351
Owner or operator: MCI MEDICAL CONCEPT INNOVATION INC. (10057752)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 21, 2018
Registered through: 2026
Brand names listed: A011.1000 STRAIGHT MICRO PLATE 4H, A011.1002 STRAIGHT MICRO PLATE 6H, A011.1004 STRAIGHT MICRO PLATE 8H, A011.1006 STRAIGHT MICRO PLATE 10H, A011.1012 STRAIGHT MICRO PLATE 16H, A011.1017 L MICRO PLATE BRIDGE 6MM 4H RIGHT, A011.1018 L MICRO PLATE BRIDGE 6MM 4H LEFT, A011.1019 L MICRO PLATE BRIDGE 8MM 4H RIGHT and more

Devices it lists

Device	Product code	Class	Role	Source
Cover, Burr Hole	GXR	2	Manufacturer	accessdata.fda.gov
Fastener, Plate, Cranioplasty	HBW	2	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Alterable	GWO	2	Manufacturer	accessdata.fda.gov
Pliers, Operative	EJY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Needle	FSH	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 21, 2022	K212391	MCI-Neuro Fixation System	GWO	Substantially Equivalent	Mci Medical Concept Innovation, Inc.	accessdata.fda.gov
December 5, 2019	K182758	MCI - CMF System	JEY	Substantially Equivalent	Mci Medical Concept Innovation, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.