FDA.reportPublic FDA data

510(k) K230774

Device
PERLA® TL System; TEKTONA® HV US Bone Cement
Applicant
Spineart
510(k) number
K230774
Product code
PML
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-23
Date received
2023-03-21
Regulation
888.3027
Classification name
Bone Cement, Posterior Screw Augmentation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Franck Pennesi
Address
3 Chemin De Pré Fleuri 1228 Plan Les Ouates Geneva CH

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PML#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical2026-01-22
K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.2024-06-12
K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA2023-10-20
K222789VADER® Pedicle System, G21 CementIcotec AG2023-01-09
K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.2022-12-20
K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA2022-08-26
K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA2021-10-28
K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020-10-13
K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic2020-08-19
K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation2020-03-31
K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.2019-09-19
K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2019-09-12
K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated2018-11-28
K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc.2018-03-27
K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic2017-10-23