FDA.reportPublic FDA data

SOUTHERN MEDICAL (PTY) LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038989433003898943SOUTHERN MEDICAL (PTY) LTD1N2026-01-0155 Regency, Route 21 Corporate Park, Irene, Pretoria IRENE Gauteng ZA 0062

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
211631882508693K253373Southern Craniomaxillofacial (CMF) SystemJEY2025-12-19
211631057420850K231145Axis Anterior Cervical Plate SystemKWQ2023-06-13
211631413541618K230608SPICCA Stand-Alone Cervical Fusion CagesOVE2023-08-14
211631470542951K230607SPICCA Cervical Fusion CagesODP2023-08-14
211631616574082K221447Southern Anterior Screw Fixated Cage (SASCA)OVD2022-10-14
211632039404113K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)MAX2022-12-08
211631294506708
211631526000488
211631594064657
211631683550196

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JEY12025-12-19
ODP12023-08-14
OVE12023-08-14
KWQ12023-06-13
MAX12022-12-08
OVD12022-10-14

PMN#

GUDID#

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