FDA.reportPublic FDA data

FUSION INNOVATIONS

Matched from indexed company URL: Fusion Innovations LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30199233333019923333FUSION INNOVATIONS1N2026-01-01341 N. Maitland Ave #270 Maitland FL US 32751

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
00810047770015SternaFuse® Fixation System - Locking Screw 2-PackØ3.0mm X 10mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770022SternaFuse® Fixation System - Locking Screw 2-PackØ3.0mm X 13mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770039SternaFuse® Fixation System - Locking Screw 2-PackØ3.0mm X 16mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770046SternaFuse® Fixation System - Locking Screw 4-PackØ3.0mm X 10mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770053SternaFuse® Fixation System - Locking Screw 4-PackØ3.0mm X 13mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770060SternaFuse® Fixation System - Locking Screw 4-PackØ3.0mm X 16mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770077SternaFuse® Fixation System - Locking Screw 6-PackØ3.0mm X 10mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com
00810047770084SternaFuse® Fixation System - Locking Screw 6-PackØ3.0mm X 13mm, Cancellous, Self-Drilling1-888-316-7627info@sternafuse.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3072181761040678K252661SternaFuse Ti Fixation SystemHRS2025-11-19
3072181735456240K202914SternaFuse Fixation SystemHRS2022-01-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS22025-11-19

PMN#

GUDID#