FDA.reportPublic FDA data

NOVAPPROACH SPINE, LLC

Matched from indexed company URL: NovApproach Spine

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30203073033020307303NOVAPPROACH SPINE, LLC1N2026-01-0113900 Tech City Circle Suite 300 Alachua FL US 32615

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
G07001021312060OneLIF™ - OneLIF Interbody, Medium, 13 Degree, 12mm X 6mm+1(385)588-3408ron.green@novapproachspine.com
G07001032522090OneLIF™ - OneLIF Interbody, Large, 25 Degree, 22mm X 9mm+1(385)588-3408ron.green@novapproachspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2961632018148754K211769OneLIF Intervertebral Body Replacement SystemOVD2021-09-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OVD12021-09-07

PMN#

GUDID#

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