FDA.reportPublic FDA data

SureMAX-SA

Primary DI
00817662027203
Brand
SureMAX-SA
Company
ADDITIVE IMPLANTS, LLC
Model
1
Catalog number
9100-0001-07
Device description
Cervical SA Caddie
Published
2023-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211111000SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.2021-07-16OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817662027203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817662027203008176620272038176620272030817662027203

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth127Millimeter
Height27Millimeter
Width83Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6027958857quality@additiveimplant.com

Regulatory Flags#

DUNS number
057002266
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817662027180SureMAX-SA11022-40012023-08-13
00817662027197SureMAX-SA11022-40022023-08-13
00817662027210SureMAX-SA11022-40032023-08-13
00817662026237SureMAX-SA11022-30012021-12-12
00817662026244SureMAX-SA11022-31012021-12-12
00817662026251SureMAX-SA11022-32012021-12-12
00817662026268SureMAX-SA11322-RFS142021-12-12
00817662026275SureMAX-SA11322-RFS162021-12-12
00817662026282SureMAX-SA11322-RFS182021-12-12
00817662026299SureMAX-SA11322-RFS202021-12-12
00817662026305SureMAX-SA11322-RVS142021-12-12
00817662026312SureMAX-SA11322-RVS162021-12-12
00817662026329SureMAX-SA11322-RVS182021-12-12
00817662026336SureMAX-SA11322-RVS202021-12-12
00817662024752SureMAX-SA11022-071214052021-09-30
00817662024769SureMAX-SA11022-071214062021-09-30
00817662024776SureMAX-SA11022-071214072021-09-30
00817662024783SureMAX-SA11022-071214082021-09-30
00817662024790SureMAX-SA11022-071214092021-09-30
00817662024806SureMAX-SA11022-071214102021-09-30

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Primary DI, Brand, Company table
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00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
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07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23