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BioHorizons BHEXZ

by Biohorizons Implant Systems Inc.

BioHorizons BHEXZ is a Class II device made by Biohorizons Implant Systems Inc., listed under FDA premarket submission BK120048 and listed in FDA GUDID since 11 Jan 2021 (UDI-DI 00847236015855), 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) BK120048

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 Number00847236015855 UDI-DI Date11 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK120048 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK120048 Active
  • FDA GUDID UDI-DI 00847236015855 listed 11 Jan 2021 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BioHorizons
Generic name
Haematological concentrate system
Model / reference
BHEXZ
Primary DI / UDI-DI
00847236015855
FDA product code
ORG
GMDN term
Haematological concentrate system
Device class
Class II
Regulation number
864.9245
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haematological concentrate system

Cleared under the same submission (BK120048)

and 8 more cleared under BK120048

Similar devices

Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)