FDA.reportPublic FDA data

LEVEL ONE CMF

Primary DI
10888118131260
Brand
LEVEL ONE CMF
Company
KLS-Martin L.P.
Model
50-174-04-09
Device description
SCREW, MAXDRIVE, TLTS, FASTENING, TEMPORARY CONDYLAR IMPLANT, TI-6AL-4V
Published
2021-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888118131260PrimaryGS10
00888118131263Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088811813126010888118131260
00888118131263008881181312638881181312630888118131263

GMDN Terms#

Term, Definition table
TermDefinition
Temporary mandibular condyle prosthesisAn 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 in the form of the mandibular condyle (head) with an incorporated base plate, and is made of metal or synthetic material.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
5
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

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
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
00841036091507"""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