FDA.report

510(k) K192208

Device
CORNICE Cervical Spacer System
Applicant
Legend Spine Technologies
510(k) number
K192208
Product code
ODP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-09
Date received
2019-08-14
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Steve Marinelli
Address
1803 Apple Tree Ln. Bethlehem PA US 18015 18015

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
B638CN1714P06040CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06120CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06110CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06100CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06090CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06080CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06070CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06060CorniceLEGEND SPINE LLC2020-10-16
B638CN1714P06050CorniceLEGEND SPINE LLC2020-10-16
B638CN1210P06080CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06120CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06110CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06100CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06090CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06080CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06070CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06060CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06050CorniceLEGEND SPINE LLC2020-04-30
B638CN1412P06040CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06120CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06110CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06100CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06090CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06070CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06060CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06050CorniceLEGEND SPINE LLC2020-04-30
B638CN1210P06040CorniceLEGEND SPINE LLC2020-04-30
B638CN0010CorniceLEGEND SPINE LLC2020-02-10
B638CN0000CorniceLEGEND SPINE LLC2020-02-10
B638CN1412T06070CorniceLEGEND SPINE LLC2020-02-10

Other 510(k) Records For Product Code ODP  

510(k)DeviceApplicantDecision date
K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.2026-05-16
K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.2026-05-12
K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.2026-04-24
K253260ORIO-3D Cage SystemSpineCraft2026-04-16
K260340HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGESHC Biologics, LLC2026-04-13
K242303MOD-COrthomod, LLC2026-04-01
K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine2026-03-30
K252432Flex-Z™ Cervical CageSpinepoint, LLC2026-03-25
K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC2026-02-13
K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2026-01-16
K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.2026-01-15
K252219Cervical Interbody and VBR Fusion SystemSync Surgical2026-01-14
K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies2026-01-08
K252894aprevo® cervical interbody systemCarlsmed, Inc.2026-01-06
K252781MSFX MIKRON PEEK CAGESMikron Makina Sanayi VE Tic. Ltd. Sti.2025-12-19

Legacy Summary

summary

FDA Review

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