FDA.reportPublic FDA data

NOVAPPROACH SPINE, LLC

Matched from indexed company URL: Novapproach Spine, LLC

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
G070010107100720OneLIF™ - OneLIF Cage, Small, 7 Degree, 10mm X 7mm - Oblique+1(385)588-3408ron.green@novapproachspine.com
G070010307100620OneLIF™ - OneLIF Cage, Large, 7 Degree, 10mm X 6mm - Oblique+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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