FDA.reportPublic FDA data

LEVEL ONE CMF

Primary DI
00888118080332
Brand
LEVEL ONE CMF
Company
KLS-Martin L.P.
Model
51-211-17-09
Device description
PLATE, FRACTURE, UPPER RAMUS, SMART, LEFT, 2.3 MM SCREW, TI-6AL-4V
Published
2016-03-24
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118080332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118080332008881180803328881180803320888118080332

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

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
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118153746DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153753DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153777DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153784DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153807DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153814DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153838DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153845DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153869DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153876DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153890DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153906DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153920DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153937DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153951DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153968DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153982DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153999DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153767DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153798DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153828DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153859DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153880DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153910DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153941DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153972DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118154009DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
07613327682717NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
07613327682724NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
00888118145376IPSKLS-Martin L.P.MQN2025-09-24