FDA.report

510(k) K221926

Device
Invictus® Bone Cement, Invictus Spinal Fixation System
Applicant
Alphatec Spine, Inc.
510(k) number
K221926
Product code
PML
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-20
Date received
2022-07-01
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Aditya Aiyer
Address
1950 Camino Vide Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376507668InvictusALPHATEC SPINE, INC.2023-04-19
00190376507644InvictusALPHATEC SPINE, INC.2023-04-19
00190376507484InvictusALPHATEC SPINE, INC.2023-04-19
00190376507439InvictusALPHATEC SPINE, INC.2023-04-19
00190376507446InvictusALPHATEC SPINE, INC.2023-04-19
00190376507682InvictusALPHATEC SPINE, INC.2023-04-19
00190376507392InvictusALPHATEC SPINE, INC.2023-04-19
00190376507507InvictusALPHATEC SPINE, INC.2023-04-19
00190376507514InvictusALPHATEC SPINE, INC.2023-04-19
00190376507415InvictusALPHATEC SPINE, INC.2023-04-19
00190376507637InvictusALPHATEC SPINE, INC.2023-04-19
00190376507583InvictusALPHATEC SPINE, INC.2023-04-19
00190376507590InvictusALPHATEC SPINE, INC.2023-04-19
00190376507491InvictusALPHATEC SPINE, INC.2023-04-19
00190376507545InvictusALPHATEC SPINE, INC.2023-04-19
00190376507651InvictusALPHATEC SPINE, INC.2023-04-19
00190376507606InvictusALPHATEC SPINE, INC.2023-04-19
00190376507569InvictusALPHATEC SPINE, INC.2023-04-19
00190376507460InvictusALPHATEC SPINE, INC.2023-04-19
00190376507408InvictusALPHATEC SPINE, INC.2023-04-19
00190376507521InvictusALPHATEC SPINE, INC.2023-04-19
00190376507477InvictusALPHATEC SPINE, INC.2023-04-19
00190376507613InvictusALPHATEC SPINE, INC.2023-04-19
00190376507552InvictusALPHATEC SPINE, INC.2023-04-19
00190376507675InvictusALPHATEC SPINE, INC.2023-04-19
00190376507620InvictusALPHATEC SPINE, INC.2023-04-19
00190376507422InvictusALPHATEC SPINE, INC.2023-04-19
00190376484419InvictusALPHATEC SPINE, INC.2023-04-19
00190376507576InvictusALPHATEC SPINE, INC.2023-04-19
00190376507538InvictusALPHATEC SPINE, INC.2023-04-19

Other 510(k) Records For Product Code PML

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
K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart2023-06-23
K222789VADER® Pedicle System, G21 CementIcotec AG2023-01-09
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