FDA.reportPublic FDA data

N/A

Primary DI
00841036138660
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
06-2130
Catalog number
06-2130
Published
2015-10-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWNPROSTHESIS, LARYNX (STENTS AND KEELS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWNProsthesis, Larynx (Stents And Keels)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896667000LORENZ STENTWalter Lorenz Surgical, Inc.1990-02-22FWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036138660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036138660008410361386608410361386600841036138660

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric laryngeal stentA sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g., silicone) intended to conform to the endolaryngeal surface. Disposable devices intended to assist implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14063107101646Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101653Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101660Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101677Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101684Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101691Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101707Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101714Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101721Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101738Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107100441Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100465Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100472Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100489Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100496Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100502Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100519Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100526Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100533Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100540Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100445Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100469Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100476Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100483Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100490Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100506Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100513Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100520Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100537Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100544Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29