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Actifuse Flow 506005078078

by Apatech Ltd

Actifuse Flow 506005078078 is a Class II device made by Apatech Ltd, cleared under FDA 510(k) K181306 on 17 Aug 2018 and listed in FDA GUDID since 10 Oct 2018 (UDI-DI 05060050780784), 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

510(k) K181306

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060050780784 UDI-DI Date10 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK181306 Date17 Aug 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181306 decided 17 Aug 2018 Active
  • FDA GUDID UDI-DI 05060050780784 listed 10 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181306
  2. Listed FDA GUDID 05060050780784

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Actifuse Flow
Generic name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
506005078078
Primary DI / UDI-DI
05060050780784
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 — 5 Milliliter

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Cleared under the same submission (K181306)

Similar devices

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

Other devices from Apatech Ltd

See all devices from Apatech Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)