FDA.reportPublic FDA data

Arristos

Primary DI
00084372100070
Brand
Arristos
Company
INGENIUMSPINE, LLC
Model
55015535
Device description
Polyax screw 5.5x35mm for 5.5 rod
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173126000Arisstos™ Spinal SystemIngenium Spine2017-12-05NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084372100070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084372100070000843721000700843721000700084372100070

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082805471
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843672101596Ingenix550275602022-05-14
00843672101602Ingenix550265652022-05-14
00843672101619Ingenix550275702022-05-14
00843672101626Ingenix550275752022-05-14
00843672101633Ingenix550275802022-05-14
00843672101640Ingenix550175702022-05-14
00843672101657Ingenix550175802022-05-14
00843672100216INGENIX550165452018-06-15
00843672100070INGENIX550155352018-06-15
00843672100001INGENIX550147302018-06-15
00843672100018INGENIX550147352018-06-15
00843672100025INGENIX550147402018-06-15
00843672100032INGENIX550147452018-06-15
00843672100049INGENIX550147502018-06-15
00843672100056INGENIX550147552018-06-15
00843672100087INGENIX550155402018-06-15
00843672100094INGENIX550155452018-06-15
00843672100100INGENIX550155502018-06-15
00843672100117INGENIX550155552018-06-15
00843672100124INGENIX550160302018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
04546540147257XIA IIStryker CorporationNKB2014-12-08
04546540147769XIA IIStryker CorporationNKB2014-12-08
04546540147806XIA IIStryker CorporationNKB2014-12-08
04546540147905XIA IIStryker CorporationNKB2014-12-08
04546540147912XIA IStryker CorporationNKB2014-12-08
04546540147929XIA IStryker CorporationNKB2014-12-08
04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08