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BioHorizons 400-200

by Biohorizons Implant Systems Inc.

BioHorizons 400-200 is a Class I device made by Biohorizons Implant Systems Inc., listed in FDA GUDID since 27 Oct 2020 (UDI-DI 00847236010218), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847236010218 UDI-DI Date27 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
BioHorizons
Generic name
Bone tack inserter, basic
Model / reference
400-200
Primary DI / UDI-DI
00847236010218
FDA product code
NDP
GMDN term
Bone tack inserter, basic
Device class
Class I
Regulation number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone tack inserter, basic

Similar devices

Other devices filed under FDA product code NDP (Accessories, Implant, Dental, Endosseous).

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)