FDA.reportPublic FDA data

Promethean Restorative Inc.

Matched from indexed company URL: Promethean Restorative, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304005393030400539Promethean Restorative Inc.1N2026-01-01333 Perry St Ste 210 Castle Rock CO US 80104

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810152100011FUSIO™ SI Allograft System - ALLOGRAFT INSERTER720-512-5947info-PR@prometheanrestorative.com
00810152100158FUSIO™ SI Allograft System - Guidewire, DIA 2.8mm X 340mm720-512-5947info-PR@prometheanrestorative.com
00810152100196FUSIO™ SI Allograft System - Guidewire, DIA 3.2mm X 340mm720-512-5947info-PR@prometheanrestorative.com
00810152100295FUSIO™ SI Allograft System - "Dilator, 9"""720-512-5947info-PR@prometheanrestorative.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3267191395237529K252962DYNAMIS™ Navigation SystemOLO2026-01-12
3267191621146274K251075DYNAMIS™ Implant SystemOUR2025-04-25
3267191971328764K243565DYNAMIS™ SI Screw SystemOUR2025-02-28
3267191707808136

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR22025-04-25
OLO12026-01-12

PMN#

GUDID#

200 records. Showing 1-40. Next