FDA.reportPublic FDA data

SureMAX

Primary DI
00817662024479
Brand
SureMAX
Company
ADDITIVE IMPLANTS, LLC
Model
1
Device description
Cervical Wedge Distractor, 7° Lordotic Large (15mm x 18mm) x 4.5mm
Published
2019-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182477000Cervical SpacerAdditive Implants, LLC2019-01-28ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817662024479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817662024479008176620244798176620244790817662024479

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth15Millimeter
Height4.5Millimeter
Width18Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6027958850quality@additiveimplant.com

Regulatory Flags#

DUNS number
057002266
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817662027180SureMAX-SA11022-40012023-08-13
00817662027197SureMAX-SA11022-40022023-08-13
00817662027203SureMAX-SA19100-0001-072023-08-13
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

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Primary DI, Brand, Company table
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00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
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04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
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