FDA.reportPublic FDA data

ATLAS SPINE INC.

Matched from indexed company URL: ATLAS SPINE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038556353003855635ATLAS SPINE INC.1N2026-01-011555 Jupiter Park Dr Ste 1 JUPITER FL US 33458

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
M68111230100070HiJAK™ Stand Alone - 7mm SM FP Lordotic Implant, HiJAK™ Stand Alone(561) 741-1108sales@atlasspine.com
M68111230100080HiJAK™ Stand Alone - 8mm SM FP Lordotic Implant, HiJAK™ Stand Alone(561) 741-1108sales@atlasspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
612331119828679K192570Atlas Spine Expandable Cervical Standalone Interbody SystemOVE2020-02-28
612331321215492K182418V3 Segmental Plating SystemKWQ2018-11-29
612331943367929K180675Atlas Spine Expandable Cervical Interbody SystemODP2018-06-13
612331882476791K172334Ortus™ Expandable Lumbar Interbody Fusion SystemMAX2017-10-25
612331953549238K110842ATLAS SPINE PEDICLE SCREW SYSTEMNKB2011-07-13
612331451907962K091406ATLAS SPINE SPACERMQP2009-09-04
612331897143340K081880ATLAS SPINE SPACERODP2008-10-02
612331682088016K072426ATLAS SPINE PEDICLE SCREW SYSTEMNKB2007-10-19
612331239784837K063205ATLAS SPINE VERTEBRAL BODY REPLACEMENTMQP2007-02-26
612331539594286K050588VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEMKWQ2005-04-21
612331831598591

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ42018-11-29
ODP42018-06-13
NKB42011-07-13
MQP32009-09-04
OVE12020-02-28
MAX12017-10-25

PMN#

GUDID#

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