FDA.reportPublic FDA data

CosmoLock Pedicle Screw System

Primary DI
B07311K1230000
Brand
CosmoLock Pedicle Screw System
Company
Kalitec Direct LLC
Model
11-K12-3000
Device description
Rod Holder, Curved, 5.5 mm
Published
2018-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTCPliers, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07311K1230000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041956211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B073DRK0100300CosmolockDR-K01-0030DR-K01-00302021-03-16
B073K0730000Matira07-K07-300007-K07-30002020-01-03
B07307CPR01181Matira Anterior Cervical Plate System07-CPR-011807-CPR-01182017-10-31
B07307CPR01191MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-011907-CPR-01192017-10-31
B07307CPR01201MATIRA ANTERIOR CERVICAL PLATE SYSTEM07-CPR-012007-CPR-01202017-10-31
B07307CPR01211MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012101-CPR-01212017-10-31
B07307CPR01221MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012207-CPR-01222017-10-31
B07307CPR01241MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012407-CPR-01242017-10-31
B07307CPR01261MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012607-CPR-01262017-10-31
B07307CPR01281MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-012807-CPR-01282017-10-31
B07307CPR01301MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013007-CPR-01302017-10-31
B07307CPR01321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013207-CPR-01322017-10-31
B07307CPR01341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-013407-CPR-01342017-10-31
B07307CPR02321MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023207-CPR-02322017-10-31
B07307CPR02341MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023407-CPR-02342017-10-31
B07307CPR02361MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023607-CPR-02362017-10-31
B07307CPR02381MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-023807-CPR-02382017-10-31
B07307CPR02401MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024007-CPR-02402017-10-31
B07307CPR02421MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024207-CPR-02422017-10-31
B07307CPR02441MATIRA ANTERIOR CERVICAL SYSTEM07-CPR-024407-CPR-02442017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034802690ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034803700ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034803720ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034709310ORTHOMEDORTHO-MED, INC.HTC2026-03-30
00840105223818ZOLL DENTALZoll-DentalHTC2025-09-16
00840105223825ZOLL DENTALZoll-DentalHTC2025-09-16
00840105223832ZOLL DENTALZoll-DentalHTC2025-09-16
10887587077628NASynthes GmbHHTC2024-08-21
B356KJ666140American MedicalsAmerican MedicalsHTC2024-07-11
10840199539458ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199539489ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199535900ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535962C ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535993Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
10840199536006Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
B356KJ526120American MedicalsAmerican MedicalsHTC2022-12-14
14026704799135PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799142PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799159PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799166PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799319PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799326PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704811448PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
10840199539830ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539847ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539854ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539861ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539878ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539885ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539892ForcepsKOROS U.S.A., INC.HTC2022-10-31