FDA.reportPublic FDA data

InTess C Cervical Cage System

Primary DI
B07309K01306T0
Brand
InTess C Cervical Cage System
Company
Kalitec Direct LLC
Model
09-K01-306T
Device description
Cervical Rasp, 14 x 11, 6mm, 7 Degree, Tapered
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07309K01306T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

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
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.HTR2026-08-26
04054462904037evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904099evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904105evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904006evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904013evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904020evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904051evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904068evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904075evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904082evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904112evonosevonos GmbH & Co. KGHTR2026-08-18
B382SD9213711000Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD9213711010Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD921377200Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD921381030Surgical DirectSurgical Direct, Inc.HTR2026-08-07
00810131885045ION Non CervicalSurgentec, LLCHTR2026-07-28
07640221373687SCALASpineArt SAHTR2026-07-24
00190776421915MillenniumAvalign Technologies, Inc.HTR2026-07-23
18257200103201ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103225ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103232ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103249ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103256ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103263ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200148431CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148448CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148455CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148462CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148479CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17