FDA.reportPublic FDA data

ANAX™ 5.5 SPINAL SYSTEM

Primary DI
08800037555670
Brand
ANAX™ 5.5 SPINAL SYSTEM
Company
CG MedTech Co.,Ltd.
Model
SF1811
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K231737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231737000ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.2023-10-26NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037555670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037555670088000375556708800037555670

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Regulatory Flags#

DUNS number
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13