FDA.reportPublic FDA data

Axis

Primary DI
06009527207941
Brand
Axis
Company
SOUTHERN MEDICAL (PTY) LTD
Model
CS40-12-SD
Device description
Axis Anterior Cervical Plate Screw, Fixed, 4,0 x 12
Published
2025-10-10
Public version status
New
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
06009527207941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009527207941060095272079416009527207941

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00810228161687corraCarlsmed, Inc.KWQ2026-10-05
00810228161694corraCarlsmed, Inc.KWQ2026-10-05
00810228161700corraCarlsmed, Inc.KWQ2026-10-05
00810228161717corraCarlsmed, Inc.KWQ2026-10-05
00810228161724corraCarlsmed, Inc.KWQ2026-10-05
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24