FDA.reportPublic FDA data

Titanium-Vocal-Fold-Medial-Implant

Primary DI
EHKM50010001
Brand
Titanium-Vocal-Fold-Medial-Implant
Company
Heinz Kurz GmbH
Model
5001000
Catalog number
5001000
Device description
Preformed vocal cord medialization implant
Published
2015-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991324000TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)Heinz Kurz1999-05-18KHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHKM50010001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Preformed vocal cord medialization implantA solid, implantable device used for vocal cord medialization thyroplasty (removal of a "window" of cartilage from the outside of the voice box and replacing it with a prosthesis to push a paralyzed vocal cord toward the middle of the voice box) to treat patients with unilateral vocal cord paralysis to improve voice quality. It is available in a variety of shapes, materials [e.g., titanium (Ti), silicon, hydroxyapatite - also know as hydroxylapatite (HA)], and sizes (e.g., male and female). It can be adjusted intraoperatively to exactly fit the anatomic specifications of the patient, and may or may not be held in place with sutures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49707291790info@kurzmed.com

Regulatory Flags#

DUNS number
341155720
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14250368820892Soft CliP Hook800012780001272026-05-21
14250368861062KURZ Meter incl. Tray800010680001062026-05-21
14250368861369Titanium Tweezers800013680001362026-05-21
14250368861376Titanium Micro Closing Forceps800013780001372026-05-21
14250368861406KURZ Precise Blades800014080001402026-05-21
14250368861437Trocar Handle800014380001432026-05-21
14250368861550KURZ Precise Cartilage Knife Set800015580001552026-05-21
14250368861710Cutting Forceps800017180001712026-05-21
14250368861727Micro Scissors800017280001722026-05-21
14250368861734Tray TTP-VARIAC800017380001732026-05-21
14250368861741Tray KURZ Meter800017480001742026-05-21
14250368861765Tray Cartilage Punch800017680001762026-05-21
14250368861932Cartilage Forceps Schimanski Design800019380001932026-05-21
14250368862007Cartilage Punch800020080002002026-05-21
14250368862557Sizer OMEGA CONNECTOR800055580005552026-05-21
14250368865404AC Sizer System Partial800054080005402026-05-21
14250368865503AC Sizer System Total800055080005502026-05-21
14250368885099SteadyCrimP Forceps800018880001882026-05-21
EHKM10150011Vent. Tube Tuebingen Type Gold Platinum101500110150012015-09-21
EHKM10150021Vent. Tube Tuebingen Type Gold Platinum101500210150022015-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCKHJ2026-05-07
00810235030853Prolaryn PlusMERZ NORTH AMERICA, INC.KHJ2026-02-24
00850056665292ORCA Foam PowderOrca Products, LLCKHJ2025-09-30
00850056665223ORCA FoamOrca Products, LLCKHJ2025-04-07
00850056665247ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665216ORCA FoamOrca Products, LLCKHJ2025-04-07
10850056665244ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665193ORCA Foam Orca Products, LLCKHJ2025-02-25
00850056665100ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665124ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665148ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00827002602854BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10827002602851BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10860008294347ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665001ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665025ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294333ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294357ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294388ORCA FoamOrca Products, LLCKHJ2023-09-15
10860003109974ORCA FoamOrca Products, LLCKHJ2022-02-24
10860003109981ORCA FoamOrca Products, LLCKHJ2022-02-24
10860008294309ORCA FoamOrca Products, LLCKHJ2022-02-24
08033549791063Epifilm OtologicAnika Therapeutics, Inc.KHJ2022-02-04
04260293133076GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-28
04260293133106GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133144GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133175GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133199GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133083GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133069GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-03-21