FDA.reportPublic FDA data

SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF

Primary DI
08809255541120
Brand
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF
Company
BM KOREA CO., LTD
Model
SPT1132
Device description
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Published
2017-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122518000SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGEBm Korea Co., Ltd.2013-02-15ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809255541120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809255541120088092555411208809255541120

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11Millimeter
Length32Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
557799209
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809255540024Galaxy Mis Screw SystemGXMS-55302017-07-11
08809255540031Galaxy Mis Screw SystemGXMS-55352017-07-14
08809255540048Galaxy Mis Screw SystemGXMS-55402017-07-14
08809255540055Galaxy Mis Screw SystemGXMS-55452017-07-14
08809255540062Galaxy Mis Screw SystemGXMS-55502017-07-14
08809255540079Galaxy Mis Screw SystemGXMS-55552017-07-14
08809255540086Galaxy Mis Screw SystemGXMS-55602017-07-14
08809255540093Galaxy Mis Screw SystemGXMS-65302017-07-14
08809255540109Galaxy Mis Screw SystemGXMS-65352017-07-14
08809255540116Galaxy Mis Screw SystemGXMS-65402017-07-14
08809255540123Galaxy Mis Screw SystemGXMS-65452017-07-14
08809255540130Galaxy Mis Screw SystemGXMS-65502017-07-14
08809255540147Galaxy Mis Screw SystemGXMS-65552017-07-14
08809255540154Galaxy Mis Screw SystemGXMS-65602017-07-14
08809255540161Galaxy Mis Screw SystemGXMS-75302017-07-14
08809255540178Galaxy Mis Screw SystemGXMS-75352017-07-14
08809255540185Galaxy Mis Screw SystemGXMS-75402017-07-14
08809255540192Galaxy Mis Screw SystemGXMS-75452017-07-14
08809255540208Galaxy Mis Screw SystemGXMS-75502017-07-14
08809255540215Galaxy Mis Screw SystemGB300-55352017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GLL100QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL101QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL106QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL107QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
00810017916450Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00763000880477|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.ODP2026-06-22
00763000880484|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.ODP2026-06-22
00887517729545TLXNuvasive, Inc.MAX2026-04-25
00887517729576TLXNuvasive, Inc.MAX2026-04-25
00887517729620TLXNuvasive, Inc.MAX2026-04-25
00887517729644TLXNuvasive, Inc.MAX2026-04-25
00887517729705TLXNuvasive, Inc.MAX2026-04-25
00887517729767TLXNuvasive, Inc.MAX2026-04-25
00887517729781TLXNuvasive, Inc.MAX2026-04-25
00887517824912TLXNuvasive, Inc.MAX2026-04-25