FDA.reportPublic FDA data

SASCA

Primary DI
06009527200652
Brand
SASCA
Company
SOUTHERN MEDICAL (PTY) LTD
Model
SASCA-3-37-09
Device description
SASCA Cage, 3 Hole, W37, H9, 4Deg
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221447000Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty) , Ltd.2022-10-14OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009527200652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009527200652060095272006526009527200652

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Regulatory Flags#

DUNS number
567466073
Device count
1
Lot or batch
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
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
06009527229691CMFMDS-ST-2.0X82026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982313524ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313531ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313548ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313555ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313562ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00889095311532INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311549INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311556INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311563INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311570INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311587INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19