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AHBP Press HBP-4010

by Abyrx, Inc.

AHBP Press HBP-4010 is a device classified as Unclassified made by Abyrx, Inc., cleared under FDA 510(k) K140117 on 11 Feb 2014 and listed in FDA GUDID since 12 Feb 2021 (UDI-DI 00850391007092), active as of 22 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 22 Oct 2026

Documents

510(k) K140117

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 Number00850391007092 UDI-DI Date12 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK140117 Date11 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140117 decided 11 Feb 2014 Active
  • FDA GUDID UDI-DI 00850391007092 listed 12 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140117
  2. Listed FDA GUDID 00850391007092

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AHBP Press
Generic name
Bone wax, synthetic
Model / reference
HBP-4010
Primary DI / UDI-DI
00850391007092
510(k) Number
FDA product code
MTJ
GMDN term
Bone wax, synthetic
Device class
U
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MTJ (Wax, Bone).

Other devices from Abyrx, Inc.

See all devices from Abyrx, Inc. →

Properties

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