Atlas FDA

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

FDA 510(k) clearance K192818 · decided 2020-03-31

Clearance details

K-number
K192818
Device name
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2019-10-01
Decision date
2020-03-31
Days to decision
182 days
Clearance type
Traditional
Product code
PML
Device class
2
Regulation number
888.3027
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Dynamo™ Spinal Cement; Salvo® Spine System (K260286)Spine Wave, Inc.2026-06-15
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Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809)Ulrich Medical USA2023-10-20
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774)Spineart2023-06-23
VADER® Pedicle System, G21 Cement (K222789)Icotec AG2023-01-09
Invictus® Bone Cement, Invictus Spinal Fixation System (K221926)Alphatec Spine, Inc.2022-12-20
BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256)Neo Medical SA2022-08-26
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489)Neo Medical SA2021-10-28
G21 Cement, VADER® Pedicle System (K200596)Icotec AG2020-10-13
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362)Medtronic2020-08-19
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526)CarboFix Orthopedics , Ltd.2019-09-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19