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06-2060

by Biomet Microfixation, Inc

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 10 Nov 2026

Documents

510(k) K896667

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 10 Nov 2026. What this means

Regulatory status

as of registry sync 10 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841036138646 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK896667 Date22 Feb 1990DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Polymeric laryngeal stent
Model / Ref / Catalog
06-2060
Primary DI / UDI-DI
00841036138646
510(k) Number
FDA product code
FWN
GMDN term
Polymeric laryngeal stent
Device class
Class II
Regulation number
874.3620
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Overview

AI-generated summary, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 06-2060 is a polymeric laryngeal stent. FDA lists it under the product name Prosthesis, Larynx (Stents And Keels). It is supplied non-sterile and must be sterilized before use by moist heat or steam sterilization. The device is single use and is available in a specific version or model number, 06-2060. It is also identified by catalog number 06-2060.

The 06-2060 was cleared under K896667. It is classified as Class II and has the product code FWN. The device has regulation number 874.3620. It was cleared and later entered into commercial distribution. The device does not have MRI safety information in its labeling.

Related devices

Category: Polymeric laryngeal stent

Cleared under the same submission (K896667)

Show all (12)

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Questions

AI-generated answers, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 06-2060?

    It is recorded under the GMDN device type "Polymeric laryngeal stent", which GMDN defines as "A sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively". FDA lists it under the product name "Prosthesis, Larynx (Stents And Keels)". It is recorded as Class II.

  • What are the product code and regulation of the 06-2060?

    FDA records the 06-2060 under product code FWN and regulation number 874.3620.

  • Who makes the 06-2060?

    BIOMET MICROFIXATION, INC is the manufacturer on record for the 06-2060.

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No