FDA.reportPublic FDA data

ELUTE, INC.

Matched from indexed company URL: Elute, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30219884993021988499ELUTE, INC.1N2026-01-01417 S WAKARA WAY, #3510 Salt Lake City UT US 84108

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
00199284455788BonVie+ - BonVie+ is a sterile, single-use, osteoconductive bone void filler intended to fill bony voids or gaps in the extremities and pelvis. It is supplied as a kit that includes a calcium salt and polymer powder, a mixing solution, and a silicone mat with cavities to form granules of various sizes. As the device resorbs, new bone gradually grows into the space previously occupied by the implant and replaces it during the healing process.(801)-410-4330info@elutinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3059551971503864K250346BonVie+MQV2025-02-26
3059551347439949K180853EP Granules™ BVFMQV2018-08-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV22025-02-26

PMN#

GUDID#