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01-3900

by Biomet Microfixation, Inc

01-3900 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K972420 on 11 Aug 1997 and listed in FDA GUDID since 15 Jun 2016 (UDI-DI 00841036011215), active as of 23 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 23 Oct 2026

Documents

510(k) K972420

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 Number00841036011215 UDI-DI Date15 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK972420 Date11 Aug 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K972420 decided 11 Aug 1997 Active
  • FDA GUDID UDI-DI 00841036011215 listed 15 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K972420
  2. Listed FDA GUDID 00841036011215

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Funnel chest remodelling bar
Model / Ref / Catalog
01-3900
Primary DI / UDI-DI
00841036011215
510(k) Number
FDA product code
HRS
GMDN term
Funnel chest remodelling bar
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Funnel chest remodelling bar

Cleared under the same submission (K972420)

and 8 more cleared under K972420

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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