FDA.reportPublic FDA data

Dakota ACDF System

Primary DI
00840019941556
Brand
Dakota ACDF System
Company
PRECISION SPINE, INC.
Model
71-RS-0412
Catalog number
71-RS-0412
Device description
Rasp, 0° Lordosis, 14x12 - 11/12mm
Published
2021-06-07
Public version status
New
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
00840019941556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019941556008400199415568400199415560840019941556

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934909Reform Ti39-TD-555539-TD-55552019-10-04
00840019934916Reform Ti39-TD-556039-TD-55602019-10-04
00840019934923Reform Ti39-TD-652539-TD-65252019-10-04
00840019934930Reform Ti39-TD-653039-TD-65302019-10-04
00840019934947Reform Ti39-TD-653539-TD-65352019-10-04
00840019934954Reform Ti39-TD-654039-TD-65402019-10-04
00840019934961Reform Ti39-TD-654539-TD-65452019-10-04
00840019934978Reform Ti39-TD-655039-TD-65502019-10-04
00840019934985Reform Ti39-TD-655539-TD-65552019-10-04
00840019934992Reform Ti39-TD-656039-TD-65602019-10-04
00840019935005Reform Ti39-TD-753039-TD-75302019-10-04
00840019935012Reform Ti39-TD-753539-TD-75352019-10-04
00840019935029Reform Ti39-TD-754039-TD-75402019-10-04
00840019935036Reform Ti39-TD-754539-TD-75452019-10-04
00840019935043Reform Ti39-TD-755039-TD-75502019-10-04
00840019935050Reform Ti39-TD-755539-TD-75552019-10-04
00840019935067Reform Ti39-TD-756039-TD-75602019-10-04
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04

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