510(k) clearances

Mg OSTEOREVIVE™;Mg OSTEOCRETE™

Bone Solutions, Inc. · Orthopedic

K262230Substantially EquivalentTraditionalMQV
Open FDA's page for this record
Third party flag
N
City
Colleyville
Advisory committee description
Orthopedic
Address 1
5712 Colleyville Blvd.
Address 2
Suite 210
Statement or summary
Summary
Product code
MQV
Zip code
76034
Applicant
Bone Solutions, Inc.
Decision date
2026-09-11
Decision code
SESE
Country code
US
Device name
Mg OSTEOREVIVE™;Mg OSTEOCRETE™
Advisory committee
OR
Contact
Drew Diaz
K number
K262230
State
TX
Date received
2026-06-30
Review advisory committee
OR
Postal code
76034
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Filler, Bone Void, Calcium Compound
Medical specialty description
Orthopedic
Regulation number
888.3045
Device class
2
Registration number
3005652161, 3013176080, 1417592, 3005304945, 3043620406, 1225991, 3003300673, 2029447, 3010097171, 9610921, 1000307092, 1000194445, 2029275, 3004111573, 1644312, 3009882464, 3012447612, 3008514120, 3014560508, 3010473074, 3016592693, 3004774118, 1030489, 3000215346, 3016851379, 3008522639, 1416980, 1833920, 3021988499, 3008110533, 1038671, 3006788678, 3009144915, 1319660, 1450662, 3008773560, 2531195, 1526439, 3012495575, 3014211822 +188 more
FEI number
3002980729, 3002806315, 3005652161, 3013176080, 1417592, 3005304945, 3043620406, 3003300673, 3001237758, 3010097171, 1000194445, 1000307092, 3000215205, 3002807172, 1000117860, 3004111573, 3009882464, 3012447612, 3008514120, 3014560508, 3010473074, 3016592693, 3006813973, 3000215346, 3016851379, 3008522639, 1416980, 3021988499, 3002807113, 3008110533, 1038671, 3006788678, 3009144915, 1000518731, 1450662, 3008773560, 1526439, 3012495575, 3010813691, 3003870583 +188 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.