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MagnetOs 703-001-US

by Kuros Biosciences B.V

MagnetOs 703-001-US is an orthopaedic bone void filling material (FDA Class II; FDA product code MQV, Filler, Bone Void, Calcium Compound) made by Kuros Biosciences B.V, cleared under FDA 510(k) K213111 on 10 Jan 2022 (1 earlier submission) and listed in FDA GUDID since 4 Jan 2018 (UDI-DI 08719699710009), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213111 Date10 Jan 2022DecidedStatusActive
United StatesGUDID listing Number08719699710009 UDI-DI Date4 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213111 decided 10 Jan 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08719699710009 listed 4 Jan 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161859
  2. Listed FDA GUDID 08719699710009
  3. Cleared FDA 510(k) K213111

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MagnetOs
Generic name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / reference
703-001-US
Primary DI / UDI-DI
08719699710009
510(k) Number
FDA product code
MQV
GMDN term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 0.05 Centiliter

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Cleared under the same submission (K161859)

and 8 more cleared under K161859

Cleared under the same submission (K213111)

and 8 more cleared under K213111

Similar devices

Other devices filed under FDA product code MQV (FILLER, BONE VOID, CALCIUM COMPOUND).

Other devices from Kuros Biosciences B.V

See all devices from Kuros Biosciences B.V →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)