Facility

F & A FOUNDATION

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014527966
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	6303 E 102nd Street Tulsa, OK, US 74137
Registration status	Active · expires 2026
Parent company	F & A Foundation (dba Reign Medical) (owner-operator 10057487)
Brand names	CLENCH COMPRESSION STAPLE

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Staple, Fixation, Bone
Product code JDR (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

Class IIOngoing2026-07-15
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

FDA inspections (1)

NAI2025-05-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by F & A Foundation (dba Reign Medical)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “F & A FOUNDATION (FEI 3014527966) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014527966-f-a-foundation/

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