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International Life Sciences: FDA-registered device maker in Sandy Springs, GA, United States, 3 510(k) clearances

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

International Life Sciences is registered with the FDA (registration 3010673515) in Sandy Springs, GA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 9, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010673515
Address: 8601 Dunwoody Pl #250, Sandy Springs, GA, United States, 30350
Owner or operator: STRYKER CORP. (1811755)
Roles: Specification developer
First device listed: February 22, 2001
Registered through: 2027
Brand names listed: 3.9mm Omega Drill, 4.75mm AlphaVent and Omega Drill, 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill, ACL Workstation, BioZip System, CinchLock, Cross-Screw System, DRILL BIT and more

Devices it lists

Device	Product code	Class	Role	Source
Bit, Drill	HTW	1	Specification developer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	OWW	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament	QWJ	2	Specification developer	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
April 9, 2026	K260317	Artelon Convenience Kits	QWJ	Substantially Equivalent	International Life Sciences	accessdata.fda.gov
May 26, 2023	K230316	FlexBand; FlexPatch; FlexBand Plus	OWW	Substantially Equivalent	International Life Sciences	accessdata.fda.gov
September 2, 2020	K200503	ATL Anchors	MBI	Substantially Equivalent	International Life Sciences	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 6, 2026	98399	Class II	Ongoing	Artelon FlexBand Dynamic Matrix Ref: 31057	Augmentation devices failed bacterial endotoxin testing.	accessdata.fda.gov

Compare with other makers

Updated April 9, 2026. 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.