FDA.reportPublic FDA data

ANAX™ OCT SPINAL SYSTEM

Primary DI
08800037598448
Brand
ANAX™ OCT SPINAL SYSTEM
Company
CG MedTech Co.,Ltd.
Model
OS2015CR
Published
2025-07-10
Public version status
New
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
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251725000ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.2025-06-25NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037598448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037598448088000375984488800037598448

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
Manufacturing date on label
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
00763000992521INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00763000992552INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
07613327132359OASYSStryker CorporationNKG2015-12-04
07613327132366OASYSStryker CorporationNKG2015-12-04
04546540371508OASYSStryker CorporationNKG2015-09-14
04546540371553OASYSStryker CorporationNKG2015-09-14
04546540371560OASYSStryker CorporationNKG2015-09-14
04546540371577OASYSStryker CorporationNKG2015-09-14
04546540371584OASYSStryker CorporationNKG2015-09-14
04546540371591OASYSStryker CorporationNKG2015-09-14
04546540371607OASYSStryker CorporationNKG2015-09-14
04546540371614OASYSStryker CorporationNKG2015-09-14
04546540371621OASYSStryker CorporationNKG2015-09-14
04546540371638OASYSStryker CorporationNKG2015-09-14
04546540371645OASYSStryker CorporationNKG2015-09-14
04546540371652OASYSStryker CorporationNKG2015-09-14
04546540371669OASYSStryker CorporationNKG2015-09-14
04546540371676OASYSStryker CorporationNKG2015-09-14
04546540371683OASYSStryker CorporationNKG2015-09-14
04546540371690OASYSStryker CorporationNKG2015-09-14
04546540371706OASYSStryker CorporationNKG2015-09-14
04546540371713OASYSStryker CorporationNKG2015-09-14
04546540371720OASYSStryker CorporationNKG2015-09-14
04546540371737OASYSStryker CorporationNKG2015-09-14
04546540371744OASYSStryker CorporationNKG2015-09-14
04546540371751OASYSStryker CorporationNKG2015-09-14
04546540371768OASYSStryker CorporationNKG2015-09-14
04546540371775OASYSStryker CorporationNKG2015-09-14
04546540371782OASYSStryker CorporationNKG2015-09-14
04546540371799OASYSStryker CorporationNKG2015-09-14