FDA.reportPublic FDA data

Axis

Primary DI
06009527228236
Brand
Axis
Company
SOUTHERN MEDICAL (PTY) LTD
Model
CP3-2L-40
Device description
Axis Anterior Cervical Plate 2-Level Size 40
Published
2025-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231145000Axis Anterior Cervical Plate SystemSouthern Medical (Pty) , Ltd.2023-06-13KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009527228236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009527228236060095272282366009527228236

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Regulatory Flags#

DUNS number
567466073
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009527234176SPICCA-SPACC-O-15-14-04-122026-06-09
06009527200652SASCASASCA-3-37-092026-04-24
06009527224672CMFCNS-SD-1.5X42026-04-24
06009527224689CMFCNS-SD-1.5X52026-04-24
06009527224696CMFCNS-SD-2.0X52026-04-24
06009527226188CMFCNS-SD-2.0X62026-04-24
06009527226195CMFCNS-SD-1.5X4-G2026-04-24
06009527226201CMFCNS-SD-1.5X6-G2026-04-24
06009527226218CMFCNS-SD-1.5X5-G2026-04-24
06009527229189CMFMDS-ST-1.5X42026-04-24
06009527229196CMFMDS-ST-1.5X62026-04-24
06009527229202CMFMDS-ST-1.5X82026-04-24
06009527229219CMFMDS-ST-1.5X102026-04-24
06009527229226CMFMDS-ST-1.5X122026-04-24
06009527229233CMFMDS-ST-1.5X142026-04-24
06009527229240CMFMDS-ST-1.8X52026-04-24
06009527229257CMFMDS-ST-1.8X72026-04-24
06009527229660CMFCNS-SD-2.0X82026-04-24
06009527229677CMFMDS-ST-2.0X52026-04-24
06009527229684CMFMDS-ST-2.0X62026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13