Data / Medical devices / United States / F & A Foundation
F & A Foundation: FDA-registered device maker in Tulsa, OK, United States, 1 510(k) clearance
F & A Foundation is registered with the FDA (registration 3014527966) in Tulsa, OK, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2018. 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
- 3014527966
- Address
- 6303 E 102nd Street, Tulsa, OK, United States, 74137
- Owner or operator
- F & A Foundation (dba Reign Medical) (10057487)
- Roles
- Specification developer
- First device listed
- April 13, 2018
- Registered through
- 2026
- Brand names listed
- CLENCH COMPRESSION STAPLE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | 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 6, 2018 | K173775 | Clench Compression Staple | JDR | Substantially Equivalent | F & A Foundation, LLC D.B.A. Reign Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 15, 2026 | 99515 | Class II | Ongoing | Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-411 | Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. | accessdata.fda.gov |
Compare with other makers
Updated September 17, 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.