FDA.reportPublic FDA data

"""2.4MM"" LOCKING RECON SYSTEM"

Primary DI
00841036091507
Brand
"""2.4MM"" LOCKING RECON SYSTEM"
Company
BIOMET MICROFIXATION, INC
Model
99-2693
Catalog number
99-2693
Published
2015-10-11
Public version status
Update
Distribution status
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
NEIProsthesis, condyle, mandibular, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEIProsthesis, Condyle, Mandibular, TemporaryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002790000ADD-ON CONDYLEWalter Lorenz Surgical, Inc.2001-08-06NEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036091507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036091507008410360915078410360915070841036091507

GMDN Terms#

Term, Definition table
TermDefinition
Temporary mandibular condyle prosthesisA sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. It is typically made of metal or synthetic material and includes the condyle head with an adjustable plate for attachment to the remaining natural mandible.

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
37613327572088Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
07613327572087Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
10888118131260LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131249LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131256LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131263LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118113016LEVEL ONE CMFKLS-Martin L.P.NEI2018-01-26
00888118073471LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073488LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073501LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073518LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073532LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073570LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073492LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073553LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00841036009830"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
00841036009847"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
34546540373985NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
04546540373991NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
04546540374004NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
10887587016382NASynthes GmbHNEI2015-09-14
10887587016399NASynthes GmbHNEI2015-09-14
10887587016405NASynthes GmbHNEI2015-09-14
10887587016412NASynthes GmbHNEI2015-09-14
10887587016429NASynthes GmbHNEI2015-09-14
10887587016436NASynthes GmbHNEI2015-09-14
10887587016443MatrixMANDIBLESynthes GmbHNEI2015-09-14
10887587054537NASynthes GmbHNEI2015-09-14
10887587054544NASynthes GmbHNEI2015-09-14
10887587054551NASynthes GmbHNEI2015-09-14