FDA.reportPublic FDA data

PINNACLE GRIPTION TF

Primary DI
10603295098867
Brand
PINNACLE GRIPTION TF
Company
DEPUY (IRELAND)
Model
2217-30-558
Catalog number
221730558
Device description
PINNACLE GRIPTION TF AUGMENT FIN RASP 58 x 30
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10603295098867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329509886710603295098867

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

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