FDA.reportPublic FDA data

ANAX™ OCT SPINAL SYSTEM

Primary DI
08800037598356
Brand
ANAX™ OCT SPINAL SYSTEM
Company
CG MedTech Co.,Ltd.
Model
OS2004CR
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
08800037598356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037598356088000375983568800037598356

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
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
08800247359952UniSpace® TPLIF CageTU02302026-06-27
08800247359969UniSpace® TPLIF CageTU02402026-06-27
08800247359976UniSpace® TPLIF CageTU02502026-06-27
08800247359983UniSpace® TPLIF CageTU02602026-06-27
08800247359990UniSpace® TPLIF CageTU02702026-06-27
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192095Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192118Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192132Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192149Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192156Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192163Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192170Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192187Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192200Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192217Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192224Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192248Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192262Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192286Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24