510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Arrowhead de LLC

Peachtree City, GA, US

ARROWHEAD DE LLC appears in FDA device records in Peachtree City, GA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Arrowhead de LLC between 2017 and 2020. The busiest year on record is 2017, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Arrowhead de LLC, by decision year
YearClearances
20171
20191
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200123Accessories for the SixFix® Hexapod FixatorKTTSubstantially Equivalent
K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTTSubstantially Equivalent
K162032Arrowhead Mini-Rail FixatorKTTSubstantially Equivalent

Registered establishments

FDA registered establishments for Arrowhead de LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30088176033008817603ARROWHEAD DE LLC401 Westpark Ct Ste 200, Peachtree City, GA 30269 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2958-2026Arrow-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, 27-253535.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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain