FDA.reportPublic FDA data

ANAX™ 5.5 SPINAL SYSTEM

Primary DI
08800015972628
Brand
ANAX™ 5.5 SPINAL SYSTEM
Company
CG MedTech Co.,Ltd.
Model
SR5120TCA
Published
2018-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143417000ANAX 5.5 Spinal SystemU&I Corporation2015-02-25MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800015972628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800015972628088000159726288800015972628

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
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800037575166ANAX™ 5.5 SPINAL SYSTEMSF09612026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMSF09622026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMSF09632026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMSF09602026-09-04
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCTS02202026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCTS02402026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCTS02602026-08-19
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27
08800247359945UniSpace® TPLIF CageTU02202026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
04546540147257XIA IIStryker CorporationMNH2014-12-08
04546540147769XIA IIStryker CorporationMNH2014-12-08
04546540147806XIA IIStryker CorporationMNH2014-12-08
04546540147905XIA IIStryker CorporationMNH2014-12-08
04546540147912XIA IStryker CorporationMNH2014-12-08
04546540147929XIA IStryker CorporationMNH2014-12-08
04546540147936XIA IStryker CorporationMNH2014-12-08
04546540147974XIA IStryker CorporationMNH2014-12-08
04546540147981XIA IStryker CorporationMNH2014-12-08
04546540147998XIA IStryker CorporationMNH2014-12-08
04546540148001XIA IIStryker CorporationMNH2014-12-08
04546540148018XIA IIStryker CorporationMNH2014-12-08
04546540148025XIA IIStryker CorporationMNH2014-12-08
04546540148735XIA IIStryker CorporationMNH2014-12-08
04546540148742XIA IIStryker CorporationMNH2014-12-08
04546540148759XIA IIStryker CorporationMNH2014-12-08
04546540148766XIA IIStryker CorporationMNH2014-12-08
04546540148773XIA IIStryker CorporationMNH2014-12-08
04546540148780XIA IIStryker CorporationMNH2014-12-08
04546540148797XIA IIStryker CorporationMNH2014-12-08
04546540148803XIA IIStryker CorporationMNH2014-12-08
04546540148810XIA IIStryker CorporationMNH2014-12-08
04546540148827XIA IIStryker CorporationMNH2014-12-08
04546540148834XIA IIStryker CorporationMNH2014-12-08
04546540148841XIA IIStryker CorporationMNH2014-12-08