Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005064037

FEI Number

3005064037

Entity Name

LIFENET HEALTH

City/State/Country

Virginia Beach, VA, US

Establishment Address

1864 CONCERT DR., Virginia Beach, VA 23453, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LIFENET HEALTH (Owner Number: 9079121)

Owner / Operator Contact Address

1864 CONCERT DR., --, VIRGINIA BEACH, VA 23453, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053098

PMA Number

N/A

All Registered Proprietary Names

FlexiGRAFT GraftLink FlexiGRAFT Sutured Lateral Ankle Tendon Construct FlexiGRAFT GraftLink TS FlexiGRAFT Connect EXT FlexiGRAFT Connect FlexiGRAFT QuadLink FlexiGRAFT DualLink Allograft MIS Delivery System ViviGen MIS Delivery System PliaFX Flo CardioGRAFT-MC Decellularized Pulmonary Artery Patch Optium DBM Vesuvius DBM Putty

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-08-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-08
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-12-16
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2024-12-16
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2008-12-10
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2005-12-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2005-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LIFENET HEALTH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009672666	LifeNet Health Northwest	Renton, WA, US
3005381997	LifeNet Health	Virginia Bch, VA, US
3015724777	LifeNet Health	Plainfield, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3005381997	LifeNet Health	Virginia Bch, VA, US
3010146686	Community Blood Center dba Solvita	Kettering, OH, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3003604053	SMITH & NEPHEW INC.	ANDOVER, MA, US
3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005064037. Last updated year: 2026. Please use registration number 3005064037 when referencing this establishment in official correspondence.