FDA.report

EVOLUTION SPINE, LLC

Matched from indexed company URL: Evolution Spine LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30124284353012428435EVOLUTION SPINE, LLC1N2026-01-012300 N Haskell Ave Dallas TX US 75204

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00195860031803E3D-C Interbody System - TRIAL 20 X 14mm 7DEG 5mm-6mm+1(214)682-8536info@evolutionspine.com
00195860031810E3D-C Interbody System - TRIAL 20 X 14mm 7DEG 7mm-8mm+1(214)682-8536info@evolutionspine.com
00195860031827E3D-C Interbody System - TRIAL 20 X 14mm 7DEG 9mm-10mm+1(214)682-8536info@evolutionspine.com
00195860031834E3D-C Interbody System - TRIAL 20 X 14mm 7DEG 11mm-12mm+1(214)682-8536info@evolutionspine.com

Registered Device Listings

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
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

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KWQ42022-03-18
OVD32024-05-15
OVE22026-02-04
NKB22019-01-15
OLO12025-08-18
MAX12016-11-16
ODP12016-05-05

PMN

GUDID

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