FDA.reportPublic FDA data

CONCORDE

Primary DI
10705034454559
Brand
CONCORDE
Company
Medos International Sàrl
Model
196931015
Catalog number
288900022
Device description
CONCORDE BULLET SPINAL SYSTEM PARALLEL CAGE 9 x 15 x 31mm
Published
2016-04-20
Public version status
Update
Distribution status
Not 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
K151352000
K173787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151352000CONCORDE Bullet Spinal SystemMedos International SARL2015-10-08MAX
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
10705034454559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503445455910705034454559

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

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
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
00856879006281FIBERGRAFT Aeridyan Matrix59000063590000632021-08-04
00856879006298FIBERGRAFT Aeridyan Matrix59000015590000152021-08-04
00856879006304FIBERGRAFT Aeridyan Matrix59000030590000302021-08-04
00856879006311FIBERGRAFT Aeridyan Matrix59000200590002002021-08-04
00856879006526FIBERGRAFT BG Matrix55000170550001702021-05-24
00856879006700FIBERGRAFT BG Morsels77000110770001102021-05-19
00856879006717FIBERGRAFT BG Morsels77000060770000602021-05-19
00856879006724FIBERGRAFT BG Morsels77000020770000202021-05-19
00856879006731FIBERGRAFT BG Putty78000110780001102021-05-19
00856879006748FIBERGRAFT BG Putty78000060780000602021-05-19
00856879006755FIBERGRAFT BG Putty78000040780000402021-05-19
00856879006762FIBERGRAFT BG Putty78000020780000202021-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520193ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520209ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520216ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520223ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520230ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520247ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520254ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520261ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520278ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10