FDA.reportPublic FDA data

Explorer TO

Primary DI
10889981275594
Brand
Explorer TO
Company
Seaspine Orthopedics Corporation
Model
ET3-009200
Catalog number
ET3-009200
Device description
Caddy - Lordosis Expansion, 11mm Width
Published
2022-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10889981275594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998127559410889981275594

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable 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
10889981080877Malibu91-214791-21472016-05-02
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043966040N/ATDM Co., Ltd.MAX2026-06-08
08800043966057N/ATDM Co., Ltd.MAX2026-06-08
08800043966064N/ATDM Co., Ltd.MAX2026-06-08
08800043966071N/ATDM Co., Ltd.MAX2026-06-08
08800043966088N/ATDM Co., Ltd.MAX2026-06-08
08800043966095N/ATDM Co., Ltd.MAX2026-06-08
08800043966101N/ATDM Co., Ltd.MAX2026-06-08
08800043966118N/ATDM Co., Ltd.MAX2026-06-08
08800043966125N/ATDM Co., Ltd.MAX2026-06-08
08800043966132N/ATDM Co., Ltd.MAX2026-06-08
08800043966149N/ATDM Co., Ltd.MAX2026-06-08
08800043966156N/ATDM Co., Ltd.MAX2026-06-08
08800043966163N/ATDM Co., Ltd.MAX2026-06-08
08800043966170N/ATDM Co., Ltd.MAX2026-06-08
08800043966187N/ATDM Co., Ltd.MAX2026-06-08
08800043966194N/ATDM Co., Ltd.MAX2026-06-08
08800043966200N/ATDM Co., Ltd.MAX2026-06-08
08800043966217N/ATDM Co., Ltd.MAX2026-06-08
08800043966224N/ATDM Co., Ltd.MAX2026-06-08
08800043966231N/ATDM Co., Ltd.MAX2026-06-08
08800043966248N/ATDM Co., Ltd.MAX2026-06-08
08800043966255N/ATDM Co., Ltd.MAX2026-06-08
08800043966262N/ATDM Co., Ltd.MAX2026-06-08
08800043966279N/ATDM Co., Ltd.MAX2026-06-08
08800043966286N/ATDM Co., Ltd.MAX2026-06-08
08800043966293N/ATDM Co., Ltd.MAX2026-06-08
08800043966309N/ATDM Co., Ltd.MAX2026-06-08
08800043966316N/ATDM Co., Ltd.MAX2026-06-08
08800043966323N/ATDM Co., Ltd.MAX2026-06-08
08800043966330N/ATDM Co., Ltd.MAX2026-06-08