BONE SOLUTIONS, INC.

FDA Device Registration & Listing · Colleyville, TX, US · Registration 3008522639

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
3008522639
FEI Number
3008522639
Entity Name
BONE SOLUTIONS, INC.
City/State/Country
Colleyville, TX, US
Establishment Address
5712 Colleyville Blvd Ste 210, Colleyville, TX 76034, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Bone Solutions, Inc. (Owner Number: 10033121)
Owner / Operator Contact Address
5712 Colleyville Blvd., Suite 210, Colleyville, TX 76034, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251522
PMA Number
N/A

All Registered Proprietary Names

Mixing and Delivery System Mixing and Delivery System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-02-01
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2020-10-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-01-23
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2026-01-07
OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Orthopedic Class 2 888.3045 2026-01-07
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-01-07

Official Correspondent

Drew Diaz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bone Solutions, 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
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008522639. Last updated year: 2026. Please use registration number 3008522639 when referencing this establishment in official correspondence.
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