FDA.reportPublic FDA data

Zsfab

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30229436423022943642ZSFAB INC1Y2026-01-0196 Clematis Ave STE 2F Waltham MA US 02453

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3048411483741869K252610ZSFab Lumbar Interbody SystemMAX2025-11-25
3048411886436294K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemODP2024-11-07
3048411020608467K232150ZSFab Cervical Interbody SystemODP2023-08-18
3048411856984237K221858ZSFab Lumbar Interbody SystemMAX2022-10-14
3048411191277477K202488ZSFab Cervical Interbody SystemODP2021-01-07
3048411278048708

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODP32024-11-07
MAX22025-11-25

PMN#

GUDID#

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