FDA.reportPublic FDA data

LEVEL ONE THORACIC

Primary DI
00888118031402
Brand
LEVEL ONE THORACIC
Company
KLS-Martin L.P.
Model
24-019-17-09
Device description
STERNAL TALON, DBL FOOT, SMALL, 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
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118031402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118031402008881180314028881180314020888118031402

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

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
07613154605453MATTAStryker GmbHHRS2025-09-16
07613154320288MATTAStryker GmbHHRS2023-10-20
07613154320332MATTAStryker GmbHHRS2023-10-20
07613154320349MATTAStryker GmbHHRS2023-10-20
07613154320356MATTAStryker GmbHHRS2023-10-20
07613154320363MATTAStryker GmbHHRS2023-10-20
07613154320370MATTAStryker GmbHHRS2023-10-20
07613154320387MATTAStryker GmbHHRS2023-10-20
07613154320394MATTAStryker GmbHHRS2023-10-20
07613154320400MATTAStryker GmbHHRS2023-10-20
07613154320417MATTAStryker GmbHHRS2023-10-20
07613154320455MATTAStryker GmbHHRS2023-10-20
07613154320479MATTAStryker GmbHHRS2023-10-20
07613154320516MATTAStryker GmbHHRS2023-10-20
07613154320530MATTAStryker GmbHHRS2023-10-20
07613154320547MATTAStryker GmbHHRS2023-10-20
07613154320608MATTAStryker GmbHHRS2023-10-20
07613154320622MATTAStryker GmbHHRS2023-10-20
07613154320653MATTAStryker GmbHHRS2023-10-20
07613154320677MATTAStryker GmbHHRS2023-10-20
07613154320707MATTAStryker GmbHHRS2023-10-20
07613154320714MATTAStryker GmbHHRS2023-10-20
07613154320721MATTAStryker GmbHHRS2023-10-20
07613154320752MATTAStryker GmbHHRS2023-10-20
07613154320783MATTAStryker GmbHHRS2023-10-20
07613154320790MATTAStryker GmbHHRS2023-10-20
07613154320806MATTAStryker GmbHHRS2023-10-20
07613154320813MATTAStryker GmbHHRS2023-10-20
07613154320882MATTAStryker GmbHHRS2023-10-20
07613154320943MATTAStryker GmbHHRS2023-10-20