FDA.reportPublic FDA data

Primus

Primary DI
00840606191326
Brand
Primus
Company
SPINAL ELEMENTS, INC.
Model
ARTS-550500ACW
Device description
Rod Template, 500mm
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606191326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606191326008406061913268406061913260840606191326

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7606070121customerservice@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606185929Primus66585-0032026-09-24
00840606185936Primus66586-0122026-09-24
00840606186773Primus66586-0142026-09-24
00840606186780Primus66586-0162026-09-24
00840606187237Primus66900-0202026-09-24
00840606187244Primus66900-020-012026-09-24
00840606187251Primus66900-020-022026-09-24
00840606174923Primus66545-0552026-09-22
00840606175036Primus66585-0002026-09-22
00840606175074Primus66515-0002026-09-22
00840606175098Primus66595-0002026-09-22
00840606175135Primus66650-0002026-09-22
00840606175241Primus66690-0002026-09-22
00840606185875Primus66675-0022026-09-22
00840606185899Primus66657-0002026-09-22
00840606186544OMEGA XP11422-0022026-09-22
00840606186551OMEGA XP11412-2952026-09-22
00840606186797Primus66585-0042026-09-22
00840606190695Primus66910-0002026-09-22
00840606190701Primus66910-000-012026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298606ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298613ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298620ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298637ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298644ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298651ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298668ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298675ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298682ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298699ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298705ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298712ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298729ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857562332K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562349K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562356K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562363K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562370K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562387K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562394K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562400K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562417K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562424K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562431K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562448K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562455K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562462K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562479K2M General InstrumentsVB Spine LLCHWT2023-09-08