Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033273526

FEI Number

3033273526

Entity Name

Artelon

City/State/Country

ATL, GA, US

Establishment Address

380 Michel St. N.W, Suite A, ATL, GA 30313, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230316

PMA Number

N/A

All Registered Proprietary Names

Flexband Flexpatch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-06-10
QWJ	Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2026-06-10
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2026-06-10
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2024-10-25
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Similar Registrations

Registration Number	Establishment Name	Location
1219930	Covidien	North Haven, CT, US
3016660811	SUBCHONDRAL SOLUTIONS	Costa Mesa, CA, US
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033273526. Last updated year: 2026. Please use registration number 3033273526 when referencing this establishment in official correspondence.