ELUTE, INC.

FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3021988499

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021988499
FEI Number
3021988499
Entity Name
ELUTE, INC.
City/State/Country
Salt Lake City, UT, US
Establishment Address
417 S WAKARA WAY, #3510, Salt Lake City, UT 84108, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Elute, Inc. (Owner Number: 10085208)
Owner / Operator Contact Address
417 S WAKARA WAY, #3510, Salt Lake City, UT 84108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250346
PMA Number
N/A

All Registered Proprietary Names

EP Granules BVF BonVie+

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-05-19
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2025-07-31

Official Correspondent

Ashok Khandkar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elute, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021988499. Last updated year: 2026. Please use registration number 3021988499 when referencing this establishment in official correspondence.
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