FDA.reportPublic FDA data

Evolution

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12266303002987265EVOLUTIONEYES INC1Y2026-01-01270 JENCKES HILL RD. Esmond RI US 02917
30105894753010589475Evolution Technologies USA Inc.1Y2026-01-012657 Delta Ring Rd Ferndale WA US 98248
30124284353012428435EVOLUTION SPINE, LLC1N2026-01-012300 N Haskell Ave Dallas TX US 75204
30304188853030418885EVOLUTION DEVICES, INC.1N2026-01-011231 Stevenson Street STE 201 San Francisco CA US 94103
30353833303035383330Evolution Technologies Vietnam. Co. Ltd1N2026-01-0115A VSIP II-A Street 27 Vietnam-Singapore Industrial Park II-A V Tan Uyen Binh Duong VN 590000

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
00195860010457Skye Cervical Plate System - Cervical Plate Fixation Pin+1(214)682-8536info@evolutionspine.com
00195860014042EMERGE Anterior Cervical Plate System - CERVICAL TEMPORARY PIN THREADED+1(214)682-8536info@evolutionspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1943871082041336K260038E3D™-C Interbody SystemOVE2026-02-04
1943871454396606K250167Evolution Spine Navigation InstrumentsOLO2025-08-18
1943871691407539K241846E3D™-C Interbody SystemOVE2024-08-12
1943871432642056K240368E3D™-A Interbody SystemOVD2024-05-15
1943871001710047K232432E3D™-A Interbody SystemOVD2024-01-30
3351581804377573K230997EvoWalk 1.0 SystemGZI2023-12-28
1943871205984595K223146EVOLUTION SPINE Interbody SystemOVD2023-02-07
1943871841821482K220275EMERGE Anterior Cervical Plate SystemKWQ2022-03-18
1943872063990037K212405EMERGE™ Anterior Cervical Plate SystemKWQ2021-09-30
1943871880848781K182478Whistler Modular Pedicle Screw SystemNKB2019-01-15
1943871013577461K181554Stowe Pedicle Screw SystemNKB2018-07-27
1943871924861515K180755Vail ALIF Buttress Plate SystemKWQ2018-07-06
1943871552771451K173375Anterior Cervical Plate SystemKWQ2017-12-21
1943871122013922K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)MAX2016-11-16
1943871926488151K160324Cervical Interbody Fusion SystemODP2016-05-05
1653871857986255
1653871544633738
3354851544633738
584191749787108
1653871763686076
3354851763686076
3354851857986255

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ42022-03-18
OVD32024-05-15
OVE22026-02-04
NKB22019-01-15
OLO12025-08-18
GZI12023-12-28
MAX12016-11-16
ODP12016-05-05

PMN#

GUDID#

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