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LifeNet Health: FDA-registered device maker in Plainfield, IN, United States, 3 510(k) clearances

Name: LifeNet Health FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

LifeNet Health is registered with the FDA (registration 3015724777) in Plainfield, IN, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 21, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015724777
Address: 845 Airtech Parkway Suite 198, Plainfield, IN, United States, 46168
Owner or operator: LIFENET HEALTH (9079121)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: December 29, 2005
Registered through: 2026
Brand names listed: Allograft MIS Delivery System, FlexiGRAFT Connect, FlexiGRAFT Connect EXT, FlexiGRAFT DualLink, FlexiGRAFT GraftLink, FlexiGRAFT GraftLink TS, FlexiGRAFT QuadLink, FlexiGRAFT Sutured Lateral Ankle Tendon Construct and more

Devices it lists

Device	Product code	Class	Role	Source
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Contract manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Non-Osteoinduction	MBS	3	Manufacturer for export	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	OWY	2	Contract manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	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
November 21, 2024	K242799	PliaFX Flo	MBP	Substantially Equivalent	Lifenet Health	accessdata.fda.gov
July 13, 2020	K201338	Allograft MIS Delivery System	FMF	Substantially Equivalent	Lifenet Health	accessdata.fda.gov
November 28, 2005	K053098	OPTIUM DBM GEL AND PUTTY	MBP	Substantially Equivalent	Lifenet	accessdata.fda.gov

Compare with other makers

Updated November 21, 2024. 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.