FDA.reportPublic FDA data

CONCORD

Primary DI
00889095358230
Brand
CONCORD
Company
GLOBUS MEDICAL, INC.
Model
4129.2020S
Device description
FORTRESS-Plus Radiopaque Bone Cement, 20g
Published
2024-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162618000CONCORD Plus Radiopaque Bone CementGlobus Medical, Inc.2017-01-23NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095358230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095358230008890953582308890953582300889095358230

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25

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Primary DI, Brand, Company table
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00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLNDN2026-09-30
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08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
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08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
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