FDA.reportPublic FDA data

Softwave

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30060665123006066512SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC1Y2026-01-0110000 Avalon Blvd Suite 720 Alpharetta GA US 30009

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
675601752015422K233937OW100SPZL2024-07-09
675601176373788K231710OW100SPZL2023-09-01
675601873525554K213120OW100S (model OW100S-US)ISA2022-10-12
675601458808410K210451OrthoGold 100ISA2021-05-05
675601262005875K200926OrthoGold 100PZL2020-08-28
675602016684801K191961OrthoGoldPZL2019-11-26
675601589659426K182682OrthoGold 100ISA2018-12-21
675601999506879K062081LITHOGOLDLNS2006-11-02
675601306624398

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PZL42024-07-09
ISA32022-10-12
LNS12006-11-02

PMN#

OW100S

2024-07-09

Softwave/Trt, LLC

OW100S

2023-09-01

Softwave/Trt, LLC