2.0mm System 01-9176

by Biomet Microfixation, Inc

2.0mm System 01-9176 is a fluted surgical drill bit (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) 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 00841036061524), 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

1 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841036061524 UDI-DI	Date11 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK062842	Date4 Dec 2006Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00841036061524
FDA 510(k) database 510(k) number K062842

Across registries

2 registries list this device

FDA 510(k) K062842 decided 4 Dec 2006 Active
FDA GUDID UDI-DI 00841036061524 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

4 Dec 2006 Cleared FDA 510(k) K062842
6 Nov 2009 Recall initiated FDA recalls Z-0538-2010
11 Oct 2015 Listed FDA GUDID 00841036061524

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: "2.0mm" System
Generic name: Fluted surgical drill bit, reusable
Model / Ref / Catalog: 01-9176

Primary DI / UDI-DI: 00841036061524
510(k) Number: K062842
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

Similar devices in this category

Other devices filed under Fluted surgical drill bit, reusable.

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Properties

Sterilise before use
Single use
Prescription use
Lot / batch number

Other properties (11, all answered No)