FDA.reportPublic FDA data

CUTTING EDGE SPINE

Matched from indexed company URL: Cutting Edge Spine, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091297353009129735CUTTING EDGE SPINE1N2026-01-016012 Waxhaw Highway Mineral Spgs NC US 28108

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
00841193127521EVOL®ha-Hyper C Cervical Interbody System - EVOL® HA Cervical Cage 14x12x05x7 deg+1(704)243-0892B.Roof@cuttingedgespine.com
00841193127538EVOL®ha-Hyper C Cervical Interbody System - EVOL® HA Cervical Cage 14x12x06x7 deg+1(704)243-0892B.Roof@cuttingedgespine.com
00841193127545EVOL®ha-Hyper C Cervical Interbody System - EVOL® HA Cervical Cage 14x12x07x7 deg+1(704)243-0892B.Roof@cuttingedgespine.com
00841193127552EVOL®ha-Hyper C Cervical Interbody System - EVOL® HA Cervical Cage 14x12x08x7 deg+1(704)243-0892B.Roof@cuttingedgespine.com
00841193127569EVOL®ha-Hyper C Cervical Interbody System - EVOL® HA Cervical Cage 14x12x09x7 deg+1(704)243-0892B.Roof@cuttingedgespine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1298012027682429K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemODP2025-03-12
1298011504612651K214123T-FIX® 3DSI Joint Fusion SystemOUR2022-06-24
1298011436529379K200991EVOL Spinal Interbody SystemMAX2020-05-13
1298011465761855K200552EVOS Lumbar Interbody SystemMAX2020-04-02
1298011843772658K192497EVOL ha - D Lateral Interbody Fusion SystemMAX2020-01-06
1298011479254892K190025EVOL® -SI Joint Fusion SystemOUR2019-08-12
1298011497311741K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemMAX2018-05-04
1298011394318474K180674EVOL® ha-C Cervical Interbody Fusion SystemODP2018-06-25
1298011704012951K150321EVOS Lumbar Interbody SystemMAX2015-07-13
1298011606596955K102957CUTTING EDGE SPINE INTERBODY FUSION DEVICEMAX2011-04-28
1298012068794473K051044ARCTEC SEMIRIGID PLATING SYSTEMMNH2005-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX62020-05-13
ODP22025-03-12
OUR22022-06-24
MNH12005-10-07

PMN#

GUDID#

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