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Mg OSTEOCRETE™ bone graft substitute

FDA UDI

Class II (US FDA UDI)

by Bone Solutions, Inc.

Identity

Trade Name
Mg OSTEOCRETE™ bone graft substitute FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only. FDA UDI
Model / Reference
10cc FDA UDI
Description
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only. FDA UDI

Identifiers

Catalog Number
44-100-00-BSI FDA UDI
Primary DI / UDI-DI
B4474410000BSI0 FDA UDI
FDA Product Code
OIS FDA UDI
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

Mg OSTEOCRETE™ bone graft substitute by Bone Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bone Solutions, Inc.

Sources (1)

  • FDA UDI b3223471-648e-42a9-994f-7a268fd66b63 35 fields · synced Jun 8, 2026