FDA.reportPublic FDA data

ARROWHEAD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12215391221539ARROWHEAD ATHLETICS1N2026-01-01220 Andover St ANDOVER MA US 01810
30088176033008817603ARROWHEAD DE LLC1N2026-01-01401 Westpark Ct Ste 200 Peachtree City GA US 30269
19334701000510697ARROWHEAD SCIENTIFIC, INC.1N2020-04-2511006 Strang Line Rd LENEXA KS US 66215
10004045161000404516ARROWHEAD DENTAL INC.1N2020-04-2511170 S State St Sandy UT US 84070
30076392463007639246Arrowhead Healthcare Supply1Y2020-04-256100 Waseca St Suite 300 Duluth MN US 55807

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00855967006400AMDT Mini-Rail - Bone Screw ø3.0 mm X 100mm long, 20mm thread901-853-4366INFO@ArrowheadDevices.com
00855967006417AMDT Mini-Rail - Bone Screw ø3.0 mm X 60mm long, 25mm thread901-853-4366INFO@ArrowheadDevices.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1579611836411715K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCELRK1997-09-29
1224351020667298K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT2019-05-14
1224351840315191K180539Deformity Analysis and Correction Software (DACS) and InstrumentationOSN2018-08-13
1579611778143328K170053Meridian PMLRK2017-11-28
1224351689651347K162032Arrowhead Mini-Rail FixatorKTT2017-02-21
1579611322814955K151295Biodenta Customized Abutment - TitaniumNHA2015-12-01
1224351703082216K112675ARROW-LOK DIGITAL SYSTEMHTY2011-12-12
1224351305237002K100926ARROWHEAD FIXATION DEVICEHTY2010-10-29
1579611737400790
1029151849097291
512092012814462
16611845898421
16611920775003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HTY42011-12-12
KTT22019-05-14
LRK22017-11-28
OSN12018-08-13
NHA12015-12-01

NDC#

PMN#

Applications#

GUDID#

80 records. Showing 1-40. Next