Primus

Primary DI
00840466901851
Brand
Primus
Company
SPINAL ELEMENTS, INC.
Model
66023-105-040
Device description
10.5mm x 40mm, Primus DualFix
Published
2026-07-21
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
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840466901851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840466901851008404669018518404669018510840466901851

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00840466901035Primus66019-0452026-07-21
00840466901042Primus66020-0452026-07-21
00840466901059Primus66021-0452026-07-21
00840466901066Primus66022-0452026-07-21
00840466901073Primus66024-0452026-07-21
00840466901080Primus66025-0452026-07-21
00840466901097Primus66026-0452026-07-21
00840466901103Primus66523-065-0452026-07-21
00840466901110Primus66009-0452026-07-21
00840466901127Primus66010-0452026-07-21
00840466901141Primus66012-0452026-07-21
00840466901158Primus66014-0452026-07-21
00840466901165Primus66015-0452026-07-21
00840466901172Primus66016-0452026-07-21
00840466901479Primus66023-075-0302026-07-21
00840466901486Primus66023-075-0352026-07-21
00840466901493Primus66023-075-0402026-07-21
00840466901509Primus66023-075-0452026-07-21
00840466901516Primus66023-075-0502026-07-21
00840466901523Primus66023-075-0552026-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157082178ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082284ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23