FDA.reportPublic FDA data

FUSION INNOVATIONS

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
00810047770275SternaFuse® Fixation System - Straight Plate6 Holes1-888-316-7627info@sternafuse.com
00810047770299SternaFuse® Fixation System - V Plate4 Holes1-888-316-7627info@sternafuse.com
00810047770343SternaFuse® Fixation System - Six-Terminal Limo Link6 Holes x 1 Snap1-888-316-7627info@sternafuse.com
00810047770350SternaFuse® Fixation System - Variable Duo Assembly, SmallVar. Duo Base x 1, Sm. Term. Link x 21-888-316-7627info@sternafuse.com
00810047770435SternaFuse® Fixation System - Terminal Link, Small, 2-Pack1 Hole x 1 Snap1-888-316-7627info@sternafuse.com
00810047770602SternaFuse® Fixation System - Disposable Driver BitAO Connection, Standard1-888-316-7627info@sternafuse.com
00810047770619SternaFuse® Fixation System - Disposable Driver Bit, 2-PackAO Connection, Standard18883167627info@sternafuse.com
00810047770657SternaFuse® Fixation System - Two-Terminal Limo Link, 2-Pack2 Holes x 1 Snap1-888-316-7627info@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#