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1.5mm System 01-7144

by Biomet Microfixation, Inc

1.5mm System 01-7144 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K062842 on 4 Dec 2006 and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036013165), 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) K062842

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 Number00841036013165 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062842 Date4 Dec 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062842 decided 4 Dec 2006 Active
  • FDA GUDID UDI-DI 00841036013165 listed 11 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0538-2010 FDA Unclassified (pre-2012) initiated 6 Nov 2009

    The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).

Timeline

3 dated events

  1. Cleared FDA 510(k) K062842
  2. Recall initiated FDA recalls Z-0538-2010
  3. Listed FDA GUDID 00841036013165

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
"1.5mm" System
Generic name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
01-7144
Primary DI / UDI-DI
00841036013165
510(k) Number
FDA product code
HBE
GMDN term
Fluted surgical drill bit, reusable
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K062842)

and 8 more cleared under K062842

Similar devices in this category

Other devices filed under Fluted surgical drill bit, reusable.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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