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Ribfix Blu System 76-0001

by Biomet Microfixation, Inc 2 variants

Ribfix Blu System 76-0001 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K142823 on 25 Feb 2015 and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036184391), 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) K142823

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 Number00841036184391 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142823 Date25 Feb 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142823 decided 25 Feb 2015 Active
  • FDA GUDID UDI-DI 00841036184391 listed 11 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142823
  2. Listed FDA GUDID 00841036184391

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ribfix Blu System
Generic name
Implant handling forceps, scissors-like
Model / Ref / Catalog
76-0001
Primary DI / UDI-DI
00841036184391
510(k) Number
FDA product code
HRS
GMDN term
Implant handling forceps, scissors-like
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code HRS (PLATE, FIXATION, BONE).

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)