Data / Medical devices / United States / Artelon
Artelon: FDA-registered device maker in Atl, GA, United States, 3 510(k) clearances
Artelon is registered with the FDA (registration 3033273526) in Atl, GA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 9, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033273526
- Address
- 380 Michel St. N.W Suite A, Atl, GA, United States, 30313
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | QWJ | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
- All makers of Bit, Drill
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.