FDA.reportPublic FDA data

Dakota ALIF System

Primary DI
00840019969017
Brand
Dakota ALIF System
Company
PRECISION SPINE, INC.
Model
69-RS-1517
Catalog number
69-RS-1517
Device description
30 X 26 X 17mm X 15° Trial Rasp
Published
2025-03-13
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
HRTStripper, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019969017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019969017008400199690178400199690170840019969017

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04
00840019934879Reform Ti39-TD-554039-TD-55402019-10-04
00840019934886Reform Ti39-TD-554539-TD-55452019-10-04
00840019934893Reform Ti39-TD-555039-TD-55502019-10-04
00840019935074Reform Ti39-TD-757039-TD-75702019-10-04
00840019935081Reform Ti39-TD-758039-TD-75802019-10-04
00840019935098Reform Ti39-TD-853539-TD-85352019-10-04
00840019935104Reform Ti39-TD-854039-TD-85402019-10-04
00840019935111Reform Ti39-TD-854539-TD-85452019-10-04
00840019935128Reform Ti39-TD-855039-TD-85502019-10-07
00840019935159Reform Ti39-TD-857039-TD-85702019-10-07
00840019935166Reform Ti39-TD-858039-TD-85802019-10-07
00840019935173Reform Ti39-TD-859039-TD-85902019-10-07
00840019935180Reform Ti39-TD-850039-TD-85002019-10-07
00840019935197Reform Ti39-TD-851139-TD-85112019-10-07
00840019935203Reform Ti39-TD-851239-TD-85122019-10-07
00840019935210Reform Ti39-TD-954039-TD-95402019-10-07
00840019935227Reform Ti39-TD-954539-TD-95452019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405953MillenniumAvalign Technologies, Inc.HRT2026-07-26
07613327651164VersiQuadSTRYKER CORPORATIONHRT2026-07-16
10845854087534Infinity™Conmed CorporationHRT2026-06-10
10845854087541Infinity™Conmed CorporationHRT2026-06-10
B7685410360Buxton BioMedicalBuxton Biomedical IncHRT2026-06-02
05055445944728SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944735SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944742SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944759SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944766SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944773SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944780SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944797SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944827SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944834SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304495SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304501SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304518SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346211SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346235SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346242SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
00190776419929MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776419936MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416249MillenniumAvalign Technologies, Inc.HRT2026-02-12
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02