← Back to catalogue

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 Granules 15cc 250-1000µm USA FDA UDI
Model / Reference
703-023-US FDA UDI
Description
MagnetOs Granules 15cc 250-1000µm USA FDA UDI

Identifiers

Primary DI / UDI-DI
08719699710221 FDA UDI
510(k) Number
K161859 FDA UDI
K213111 FDA UDI
K232347 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

Dimensions & Sizes

Size
Total Volume — 1.5 Centiliter 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

K161859 also covers:

K213111 also covers:

K232347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kuros Biosciences B.V

Sources (1)

  • FDA UDI b8eaf650-42d0-451a-b1d5-1fa0ef6a8a91 35 fields · synced May 30, 2026