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IMPIX 3D Print B242E08062810

by Medicrea International SA

IMPIX 3D Print B242E08062810 is a Class II device made by Medicrea International SA, cleared under FDA 510(k) K163595 on 13 Nov 2017 and listed in FDA GUDID since 2 Nov 2018 (UDI-DI 03613720273127), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K163595

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03613720273127 UDI-DI Date2 Nov 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163595 Date13 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163595 decided 13 Nov 2017 Active
  • FDA GUDID UDI-DI 03613720273127 listed 2 Nov 2018 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2452-2023 FDA Class II initiated 12 Jul 2023

    There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

    • Terminated Z-1156-2020 FDA Class II initiated 2 Oct 2019

    Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Timeline

4 dated events

  1. Cleared FDA 510(k) K163595
  2. Listed FDA GUDID 03613720273127
  3. Recall initiated FDA recalls Z-1156-2020
  4. Recall initiated FDA recalls Z-2452-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IMPIX 3D Print
Generic name
Metallic spinal interbody fusion cage
Model / reference
B242E08062810
Primary DI / UDI-DI
03613720273127
510(k) Number
FDA product code
MAX
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K163595)

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Other devices from Medicrea International SA

See all devices from Medicrea International SA →

Properties

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