Data / Medical devices / United States / Arrowhead De LLC
Arrowhead De LLC: FDA-registered device maker in Peachtree City, GA, United States, 2 510(k) clearances
Arrowhead De LLC is registered with the FDA (registration 3008817603) in Peachtree City, GA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008817603
- Address
- 401 Westpark Ct Ste 200, Peachtree City, GA, United States, 30269
- Owner or operator
- Arrowhead DE LLC (10034076)
- Roles
- Specification developer
- First device listed
- November 3, 2010
- Registered through
- 2026
- Brand names listed
- Arrow-Lok
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | 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 |
|---|---|---|---|---|---|---|
| December 12, 2011 | K112675 | ARROW-LOK DIGITAL SYSTEM | HTY | Substantially Equivalent | Arrowhead Medical Device Technologies, LLC | accessdata.fda.gov |
| October 29, 2010 | K100926 | ARROWHEAD FIXATION DEVICE | HTY | Substantially Equivalent | Arrow Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2026 | 99383 | Class II | Ongoing | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533 | Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 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.