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Direct Inject 79-45910

by Stryker Leibinger

Direct Inject 79-45910 is a Class II device made by Stryker Leibinger, cleared under FDA 510(k) K143661 on 2 Sep 2015 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613327123272), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K143661

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 Number07613327123272 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143661 Date2 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143661 decided 2 Sep 2015 Active
  • FDA GUDID UDI-DI 07613327123272 listed 24 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1436-2021 FDA Class II initiated 1 Apr 2021

    Inability for the user to inject the paste from the syringe into the target location.

Timeline

3 dated events

  1. Cleared FDA 510(k) K143661
  2. Listed FDA GUDID 07613327123272
  3. Recall initiated FDA recalls Z-1436-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Direct Inject
Generic name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
79-45910
Primary DI / UDI-DI
07613327123272
510(k) Number
FDA product code
GXP
GMDN term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device class
Class II
Regulation number
882.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Cleared under the same submission (K143661)

Similar devices

Other devices filed under FDA product code GXP (METHYL METHACRYLATE FOR CRANIOPLASTY).

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)