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MagnetOs

FDA UDI

Class II (US FDA UDI)

by Kuros Biosciences B.V

Identity

Trade Name
MagnetOs FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
MagnetOs Flex Matrix 10.08cc 0.25-1mm Large FDA UDI
Model / Reference
703-058-US FDA UDI
Description
MagnetOs Flex Matrix 10.08cc 0.25-1mm Large FDA UDI

Identifiers

Primary DI / UDI-DI
08719699712188 FDA UDI
510(k) Number
K213959 FDA UDI
K233245 FDA UDI
FDA Product Code
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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Category: Bone matrix implant, synthetic, non-antimicrobial

MagnetOs by Kuros Biosciences B.V — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K213959 also covers:

K233245 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kuros Biosciences B.V

Sources (1)

  • FDA UDI e7cd4a7b-24d8-452c-81bb-cd84d6f2b4b5 34 fields · synced May 31, 2026