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510(k) K212980

Device
Tesera-k ALIF System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K212980
Product code
OVD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-07
Date received
2021-09-17
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott Rucker
Address
1200 California St. Suite 210 Redlands CA US 92374 92374

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis2026-09-11
K261408SABER-XA SystemElevation Spine2026-08-03
K261809Interwedge® Standalone LateralFoundation Surgical Group2026-07-31
K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.2026-07-15
K260810Anteralign LS coverplateTyber Medical, LLC2026-06-10
K254202MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05
K253401SCRIPT™ Implant SystemGlobus Medical, Inc.2026-04-29
K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.2026-02-25
K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2025-12-08
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine2025-09-03
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.2025-07-10
K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18
K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30

Legacy Summary#

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FDA Review#

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