FDA.reportPublic FDA data

CONCORDE

Primary DI
10705034139906
Brand
CONCORDE
Company
Medos International Sàrl
Model
187827109
Catalog number
187827109
Device description
CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 x 9 x 27mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041722000
K052746000
K081917000
K151773000
K173787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041722000MODIFICATION TO VBR SPINAL SYSTEMDepuy Spine, Inc.2004-09-23MQP
K052746000CONCORDE VBR SPINAL SYSTEMDepuy Spine, Inc.2005-10-21MQP
K081917000DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMSDepuy Spine, Inc.2009-05-22MAX
K151773000CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015-11-20MAX
K173787000X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® SystemMedos International SARL2018-06-11MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034139906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503413990610705034139906

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322691458Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691533Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691540Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691557Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691564Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691571Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691588Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691595Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691601Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861110Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861127Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861134Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861295Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861301Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861318Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861325Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861332Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861349Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861356Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861363Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861370Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861387Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861394Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861400Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19