FDA.reportPublic FDA data

Explorer TO

Primary DI
10889981206895
Brand
Explorer TO
Company
Seaspine Orthopedics Corporation
Model
ET1-403212
Catalog number
ET1-403212
Device description
Height Expansion, 11mm x 32mm x 12-16mm, 0 Deg
Published
2023-03-24
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212540000Explorer TO SystemSeaSpine Orthopedics Corporation2021-09-10MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981206895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998120689510889981206895

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981206116BoneSyncABS-3202ABS-32022019-10-10
10889981206123BoneSyncABS-3205ABS-32052019-10-10
10889981206130BoneSyncABS-3210ABS-32102019-10-10
10889981206147BoneSyncABS-3215ABS-32152019-10-10
10889981206154BoneSyncABS-3310ABS-33102019-10-10
10889981206161BoneSyncABS-3315ABS-33152019-10-10
10889981308933Cove02-9200-01302-9200-0132023-10-30
10889981308940Cove02-9200-02502-9200-0252023-10-30
10889981308957Cove02-9200-05002-9200-0502023-10-30
10889981308964Cove02-9200-10002-9200-1002023-10-30
10889981308971Cove02-9300-05002-9300-0502023-10-30
10889981308988Cove02-9300-10002-9300-1002023-10-30
10889981308995Cove02-9300-15002-9300-1502023-10-30
10889981309008Cove02-9300-30002-9300-3002023-10-30
10889981309022OsteoCove56920013569200132023-10-30
10889981309039OsteoCove56920025569200252023-10-30
10889981309046OsteoCove56920050569200502023-10-30
10889981309053OsteoCove56920100569201002023-10-30
10889981309060OsteoCove56930050569300502023-10-30
10889981309077OsteoCove56930100569301002023-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
07640139342287Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19